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

Sponsor:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00921427

Purpose

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.

Condition	Intervention	Phase
Hemianopia Quadrantanopia Scotoma Visual Field Loss	Behavioral: Vision Restoration Therapy (VRT) Device: Transcranial direct current stimulation (tDCS)	Phase 0

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Visual Field Gain in Degrees [ Time Frame: Once every month for three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Field test- Percent accuracy of detection [ Time Frame: Once every month for three months ] [ Designated as safety issue: No ]
Functional Questionnaire (Impact of Vision Impairment Profile) [ Time Frame: Once every month for three months ] [ Designated as safety issue: No ]
Subjective Drawing of the Visual Field (area of blind field in sq. mm) [ Time Frame: Once every month for three months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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) 30 min, twice a day, 3 days a week, 12 weeks Device: Transcranial direct current stimulation (tDCS) 2 mA/min, 30 min, twice a day, 3 days a week for 12 weeks
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) 30 min, twice a day, 3 days a week, 12 weeks

Arms

Assigned Interventions

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)

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

Device: Transcranial direct current stimulation (tDCS)

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

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)

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921427

Contacts

Contact: Ela Bhatt, PhD PT	617-667-0367	ebhatt@bidmc.harvard.edu
Contact: Souzana Obretenova	617-667-0205	sobreten@bidmc.harvared.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ela Bhatt, PhD PT 617-667-0367 ebhatt@bidmc.harvard.edu
Contact: Souzana Obretenova 617-667-0205 sobreten@bidmc.harvard.edu
Sub-Investigator: Ela Bhatt, PhD PT
Sub-Investigator: Souzana Obretenova
Sub-Investigator: Alvaro Pascual-Leone, MD PhD
Sub-Investigator: Mark Halko, PhD
Sub-Investigator: Nurhan Torun, MD
Principal Investigator: Lotfi B Merabet, PhD OD
Massachusetts Eye and Ear Infirmary	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mary Lou Jackson, MD 617-573-4177 marylou_jackson@meei.harvard.edu
Principal Investigator: Mary Lou Jackson, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:	Lotfi B Merabet, PhD OD	Beth Israel, Harvard Medical School
Study Director:	Alvaro Pascual-Leone, MD PhD	Beth Israel, Harvard Medical School, Neurology

More Information

No publications provided

Responsible Party:	Beth Israel Deaconess Medical Center ( Dr. Lotfi B Merabet )
Study ID Numbers:	2007-P-000241
Study First Received:	June 14, 2009
Last Updated:	December 15, 2009
ClinicalTrials.gov Identifier:	NCT00921427 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:

Hemianopia
Rehabilitation
Transcranial direct current stimulation
Visual field

Additional relevant MeSH terms:

Vision Disorders
Signs and Symptoms
Sensation Disorders
Eye Diseases
Nervous System Diseases

Neurologic Manifestations
Scotoma
Blindness
Hemianopsia

ClinicalTrials.gov processed this record on February 08, 2010