The Use of Transcranial Direct Current Stimulation (TDCS) To Enhance the Rehabilitative Effect of Vision Restoration Therapy: A Pilot Study
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Status:
As of April 2009, nine patients have been enrolled. The study is ongoing and currently recruiting patients.
Purpose:
To study the effect of computer-based visual restoration therapy (VRT) in combination with noninvasive brain stimulation (TDCS) on visual recovery of patients with hemianopia and quadrantanopia.
Interventions:
Transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is the application of weak electrical currents (1-2 mA) to modulate the activity of neurons in the brain.
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Vision Restoration Therapy
maps areas where vision may be improved, and then provides customized neurostimulation therapy to regions within the brain's vision centers.
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Location(s):
Boston, Massachusetts
USA
Year Started:
2007
Design:
Interventional, Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study.
Inclusion Criteria
Hemianopic or quandrantanopic field loss as a result of post-chiasmal brain damage (stroke, aneurysm, trauma, brain surgery, tumor); hemianopic field loss is defined as (a) visual field defect on the same side of visual space in both eyes as determined by monocular perimetry and (b) established structural damage of the post-chiasmal visual system as documented by standard neuroimaging techniques (CT or MRI), medical reports, or a combination of these; deep scotoma- defined field loss as confirmed by perimetry;
cognitive, language and motor function sufficient to understand the experiments and follow instructions.
Exclusion Criteria
Ongoing use of central nervous system-active or psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications that might interfere with effects of brain stimulation; presence of additional potential TDCS risk factors: presence of an electrically, magnetically, or mechanically activated implant in the head, an intracerebral vascular clip, or any other electrically sensitive support system (ex. Cardiac pacemaker, metal plate or metal aneurysm clips); past history of seizures or unexplained losses of consciousness; history of medication-resistant epilepsy in the family.
Patient Involvement:
Patients come to Beth Israel Deaconess Medical Center, Boston, for treatment for one hour sessions, 3 days per week, for 3 months. Patients could be assigned to either of two groups: Vision Restoration Therapy and noninvasive brain stimulation or Vision Restoration Therapy and sham noninvasive brain stimulation group. In addition, patients receive a full workup (four times during the course of the study) by a neuro-ophthalmologist including visual field tests, reading ability, and a functional evaluation. Patients will be screened prior to the study by a neurologist for TDCS risk factors. Parking will be covered. Paratransit service in the state of Massachusetts will be covered. Subway, train, bus fares will be reimbursed.
Primary Outcome:
NIDEK microperimetry, High Resolution Perimetry, Functional evaluation questionnaires (Impact of Visual Impairment and Low Vision- Visual Functional Questionnaire), reading ability.
Secondary Outcome:
Visual Field test- Percent accuracy of detection;
Functional Questionnaire (Impact of Vision Impairment Profile); Subjective Drawing of the Visual Field (area of blind field in sq. mm).
Source of Information:
Correspondence with contact on 4/11/08-jh.
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 11/2/2009
Reviewed on: 11/02/2009.
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