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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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.

Detailed Summary:

The specific aim of this study is to improve recovery of visual function after brain injury. A prominent theme of current neuroscience research regarding the sequelae of brain injury posits that activity-dependent plasticity underlies neuro-recovery. If that is the case, there is good reason to believe that neurological changes underling recovery can be facilitated by established means of enhancing cortical activity. Studies suggest that altering cortical excitability may prime or prepare the cortex for subsequent training and furthermore, may improve overall functional outcomes (Webster et al, 2006; Brown & Pilitsis, 2006; Khedr et al, 2005). The working hypothesis of this pilot study is that computer-based visual rehabilitative training (using NovaVision's Vision Restoration TherapyTM; "VRT" software) enhances visual function (defined as an increase in functional visual field) by reinforcing synaptic connections within sensory networks of visual cortex associated with the visual field loss (Kasten et al., 1998; Sabel, 1999). Potentially, this reinforcement can be enhanced by concurrent transcranial direct current stimulation (TDCS) leading in turn, to enhanced visual performance (quantified by the extent of visual field measured by visual perimetry allowing for a direct statistical comparison of visual field change over time and on an individual basis) in patients with partial of complete hemianopic visual field loss caused by brain injury. Both computer based visual rehabilitative training and TDCS are established techniques and this novel approach aims to provide preliminary data regarding the safety and efficacy of a combined intervention.

We expect that results from this study will provide an objective basis for a larger, formal randomized controlled study combining the two therapies. Our long term goals are to maximize the benefits of a modern vision
Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome: Visual Field Gain in Degrees [ Time Frame: Once every month for three months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual Field test- Percent accuracy of detection [ Time Frame: Once every month for three months ]
  • Functional Questionnaire (Impact of Vision Impairment Profile) [ Time Frame: Once every month for three months ]
  • Subjective Drawing of the Visual Field (area of blind field in sq. mm) [ Time Frame: Once every month for three months ]


Original Secondary Outcome: Same as current

Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: June 14, 2009
Date Started: November 2007
Date Completion:
Last Updated: March 20, 2012
Last Verified: March 2012