Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial "NICHE"

Completed

Phase N/A Results N/A

Update History

29 Sep '17
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria : - ≥ 18 years of age - An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study; - no other known brain abnormalities by history; - A one-sided stroke resulting in upper extremity paresis - A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb Exclusion Criteria - Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump; - Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening. - Active alcohol abuse, illicit drug use or drug abuse or significant mental illness - Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial. - History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months. - Any condition that would prevent the subject from giving voluntary informed consent; - An implanted brain stimulator; - Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body; - Enrolled or plans to enroll in an interventional trial during this study; - Scalp wounds or infections; - Claustrophobia precluding MRI; - A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact; - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i - previous stroke with residual deficits (TIAs not a reason for exclusion); - premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology; - a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition, - confirmed or suspected lower-limb fracture preventing mobilization, - patients requiring palliative care - patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study - A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up. - A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up. - Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale. - Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale. - Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale. - Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale. - Patients unable to comprehend or follow verbal commands - Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition - A Mini mental status exam (MMSE) <25.
Old
Inclusion Criteria : - ≥ 18 years of age - An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study; - no other known brain abnormalities by history; - A one-sided stroke resulting in upper extremity paresis - A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb Exclusion Criteria - Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump; - Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening. - Active alcohol abuse, illicit drug use or drug abuse or significant mental illness - Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial. - History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months. - Any condition that would prevent the subject from giving voluntary informed consent; - An implanted brain stimulator; - Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body; - Enrolled or plans to enroll in an interventional trial during this study; - Scalp wounds or infections; - Claustrophobia precluding MRI; - A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact; - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i - previous stroke with residual deficits (TIAs not a reason for exclusion); - premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology; - a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition, - confirmed or suspected lower-limb fracture preventing mobilization, - patients requiring palliative care - patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study - A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up. - A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up. - Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale. - Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale. - Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale. - Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale. - Patients unable to comprehend or follow verbal commands - Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition - A Mini mental status exam (MMSE) <25.
12 Dec '15
The eligibility criteria were updated.
New
Inclusion Criteria : - ≥ 18 years of age - An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study; - no other known brain abnormalities by history; - A one-sided stroke resulting in upper extremity paresis - A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb Exclusion Criteria - Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump; - Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening. - Active alcohol abuse, illicit drug use or drug abuse or significant mental illness - Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial. - History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months. - Any condition that would prevent the subject from giving voluntary informed consent; - An implanted brain stimulator; - Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body; - Enrolled or plans to enroll in an interventional trial during this study; - Scalp wounds or infections; - Claustrophobia precluding MRI; - A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact; - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i - previous stroke with residual deficits (TIAs not a reason for exclusion); - premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology; - a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition, - confirmed or suspected lower-limb fracture preventing mobilization, - patients requiring palliative care - patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study - A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up. - A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up. - Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale. - Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale. - Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale. - Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale. - Patients unable to comprehend or follow verbal commands - Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition - A Mini mental status exam (MMSE) <25.
Old
Inclusion Criteria : - ≥ 18 years of age - An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study; - no other known brain abnormalities by history; - A one-sided stroke resulting in upper extremity paresis - A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb Exclusion Criteria - Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump; - Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening. - Active alcohol abuse, illicit drug use or drug abuse or significant mental illness - Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial. - History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months. - Any condition that would prevent the subject from giving voluntary informed consent; - An implanted brain stimulator; - Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body; - Enrolled or plans to enroll in an interventional trial during this study; - Scalp wounds or infections; - Claustrophobia precluding MRI; - A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact; - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i - previous stroke with residual deficits (TIAs not a reason for exclusion); - premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology; - a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition, - confirmed or suspected lower-limb fracture preventing mobilization, - patients requiring palliative care - patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study - A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up. - A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up. - Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale. - Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale. - Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale. - Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale. - Patients unable to comprehend or follow verbal commands - Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition - A Mini mental status exam (MMSE) <25.
A location was updated in Phoenix.
New
The overall status was removed for Mayo Clinic.
A location was updated in Downey.
New
The overall status was removed for Rancho Los Amigos National Rehabilitation Center.
A location was updated in Atlanta.
New
The overall status was removed for Shepherd Rehabilitation Center.
A location was updated in Chicago.
New
The overall status was removed for Rehabilitation Institute of Chicago.
A location was updated in Indianapolis.
New
The overall status was removed for Indiana University Indianapolis.
A location was updated in Boston.
New
The overall status was removed for Spaulding Rehabilitation Hospital.
A location was updated in New York.
New
The overall status was removed for Columbia Cornell New York Presbyterian Hospital.
A location was updated in White Plains.
New
The overall status was removed for Burke Medical Research Institute, Weill Cornell Neurology.
A location was updated in Durham.
New
The overall status was removed for Duke University Medical Center.
A location was updated in Cincinnati.
New
The overall status was removed for University of Cincinnati.
A location was updated in Columbus.
New
The overall status was removed for Ohio State University.
A location was updated in Houston.
New
The overall status was removed for TIRR Memorial Hermann Hospital.
16 Aug '14
The eligibility criteria were updated.
New
Inclusion Criteria : - ≥ 18 years of age - An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study; - no other known brain abnormalities by history; - A one-sided stroke resulting in upper extremity paresis - A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb Exclusion Criteria - Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump; - Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening. - Active alcohol abuse, illicit drug use or drug abuse or significant mental illness - Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial. - History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months. - Any condition that would prevent the subject from giving voluntary informed consent; - An implanted brain stimulator; - Any metal in head with the exception of dental work or any ferromagnetic metal elsewhere in the body; - Enrolled or plans to enroll in an interventional trial during this study; - Scalp wounds or infections; - Claustrophobia precluding MRI; - A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact; - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i - previous stroke with residual deficits (TIAs not a reason for exclusion); - premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology; - a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition, - confirmed or suspected lower-limb fracture preventing mobilization, - patients requiring palliative care - patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study - A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up. - A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up. - Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale. - Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale. - Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale. - Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale. - Patients unable to comprehend or follow verbal commands - Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition - A Mini mental status exam (MMSE) <25.
Old
Inclusion Criteria : - ≥ 18 years of age - An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study; - no other known brain abnormalities by history; - A one-sided stroke resulting in upper extremity paresis - A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb Exclusion Criteria - Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump; - Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening. - Active alcohol abuse, illicit drug use or drug abuse or significant mental illness - Patients suffering from depression as measured by a score of >10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is <10 are eligible to participate in the trial. - any history of seizure. - Any condition that would prevent the subject from giving voluntary informed consent; - An implanted brain stimulator; - Aneurysm clip or other metal in body; - Enrolled or plans to enroll in an interventional trial during this study; - Scalp wounds or infections; - Claustrophobia precluding MRI; - A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact; - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;i - previous stroke with residual deficits (TIAs not a reason for exclusion); - premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology; - a concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition, - confirmed or suspected lower-limb fracture preventing mobilization, - patients requiring palliative care - patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study - A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up. - A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up. - Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale. - Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale. - Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale. - Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale. - Patients unable to comprehend or follow verbal commands - Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition - A Mini mental status exam (MMSE) <25.