Repetitive Transcranial Magnetic Stimulation (rTMS) to Contralesional Hemisphere in Patients With Stroke for Upper Limb Recovery "ContraStim"

Completed

Phase 1/2 Results N/A

Update History

14 Jun '13
A location was updated in Chicago.
New
The overall status was removed for The Rehabilitation Institute of Chicago.
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - ≥ 18 years of age - An ischemic or hemorrhagic stroke suffered 3-9 months prior to the study - no other known brain abnormalities by history or by structural MRI - A one-sided stroke resulting in upper extremity paresis - A Chedoke Arm and Hand Activity Inventory score 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 - History of alcohol abuse, illicit drug use or drug abuse or significant mental illness - any history of epilepsy - 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 - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in the affected limb - 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 undergoing any other occupational therapy than what is provided in the study - A recent injection of botulinum 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 - Ataxia as measured by a score > 1 on item 7 (limb ataxia) 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
Old
Inclusion Criteria: - ? 18 years of age - An ischemic or hemorrhagic stroke suffered 3-9 months prior to the study - no other known brain abnormalities by history or by structural MRI - A one-sided stroke resulting in upper extremity paresis - A Chedoke Arm and Hand Activity Inventory score 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 - History of alcohol abuse, illicit drug use or drug abuse or significant mental illness - any history of epilepsy - 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 - Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale >2/4 in the affected limb - 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 undergoing any other occupational therapy than what is provided in the study - A recent injection of botulinum 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 - Ataxia as measured by a score > 1 on item 7 (limb ataxia) 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