The Use of Transcranial Direct Current Stimulation (TDCS) to Enhance the Rehabilitative Effect of Vision Restoration Therapy

NCT00921427 | Completed Early Phase 1

• 1 other identifier: 2007-P-000241
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of our study is to explore the efficacy of combination of brain stimulation with visual rehabilitation in patients with visual field loss resulting from brain lesions. It is shown that the effect of sensorimotor training of hand can be enhanced in patients with stroke using brain stimulation. We decided to explore this combination for visual field loss because visual dysfunction following brain lesions is considered intractable. We hypothesize that combination of noninvasive brain stimulation, in the form of transcranial direct current stimulation (tDCS), with visual rehabilitation would have greater efficacy than visual rehabilitation alone.

Conditions

Hemianopia; Quadrantanopia; Scotoma; Visual Field Loss

Keywords

Hemianopia; Rehabilitation; Transcranial direct current stimulation; Visual field

Outcome Measures

Primary Outcomes (1)

• Visual Field Gain in Degrees

  Once every month for three months

Secondary Outcomes (3)

• Visual Field test- Percent accuracy of detection

  Once every month for three months

• Functional Questionnaire (Impact of Vision Impairment Profile)

  Once every month for three months

• Subjective Drawing of the Visual Field (area of blind field in sq. mm)

  Once every month for three months

Study Arms (2)

VRT and active tDCS

ACTIVE COMPARATOR

Patients will receive tDCS (noninvasive brain stimulation) concurrently with vision restoration therapy. TDCS is delivered using a small battery-operated device. Electrical leads from the device are connected to saline soaked sponges that are placed at strategic locations on the skull corresponding to areas of the brain that need to be stimulated (in this case, the visual cortex). The dosage will be set to 2 mA/min for 30 minutes, twice a day for 3 days a week for 12 weeks.

Behavioral: Vision Restoration Therapy (VRT); Device: Transcranial direct current stimulation (tDCS)

VRT combined with sham tDCS

SHAM COMPARATOR

Patients will receive sham tDCS concurrently with vision restoration therapy. Electrical leads from the tDCS device will be connected to saline soaked sponges placed at strategic locations on the skull, in a similar maner as in the active tDCS group. Current will be turned on for 30 seconds but will be slowly ramped down and turned off. Treatment will continue for 3 days a week for 12 weeks.

Behavioral: Vision Restoration Therapy (VRT)

Interventions

Vision Restoration Therapy (VRT) BEHAVIORAL

30 min, twice a day, 3 days a week, 12 weeks

VRT and active tDCS; VRT combined with sham tDCS

Transcranial direct current stimulation (tDCS) DEVICE

2 mA/min, 30 min, twice a day, 3 days a week for 12 weeks

VRT and active tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-charismatic 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
• informed written consent to participate in the study
• motivation to participate in the VRT program

You may not qualify if:

• any sensory-motor loss other than visual
• ongoing use of CNS-active medications for an active neurological disease
• ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications for an active psychiatric condition
• presence of additional potential TDCS risk factors:
• Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
• Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system.
• Metal in any part of the body, including metal injury to the eye. (Jewelry must be removed during stimulation.)
• A history of medication-resistant epilepsy in the family
• Past history of seizures or unexplained spells of loss of consciousness

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

MeSH Terms

Conditions

Hemianopsia; Scotoma

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Lotfi B Merabet, OD PhD

  Beth Israel, Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Alvaro Pascual-Leone, MD PhD

  Beth Israel, Harvard Medical School, Neurology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 14, 2009
• First Posted: June 16, 2009
• Study Start: November 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2012
• Last Updated: March 21, 2012

Record last verified: 2012-03