A Pilot Trial of Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)
Abstract
Objectives and Rationale: Multiple sclerosis (MS) is the most common degenerative neurologic disorder in adults of working-age. Those with progressive forms of the disorder represent the patients with the greatest cumulative disability and also are relatively underserved with limited disease-modifying treatment options. Hand functioning, measured by strength and dexterity, often declines in MS over time and can be a frustrating symptom. Hand use is a key part of daily life and limitations can greatly impact one?s functional ability. This pilot clinical trial will test a novel treatment approach, transcranial direct current stimulation (tDCS), to enhance a program of hand rehabilitation in MS. We will utilize an innovative telemedicine protocol for at home treatment to allow access for a wide range of individuals affected by MS with varying levels of MS-related impairment, eliminating the requirements of travel and time away from work or family obligations. tDCS is a novel, safe, and well-tolerated, low-cost treatment approach. Early studies have indicated that it may be an effective treatment. tDCS is thought to work by administering low amplitude direct currents to induce changes in brain activity and response. It has been extensively studied for many clinical problems including clinical depression. tDCS has also been studied for use in healthy adults as a method to improve attention. To gain full benefit of tDCS, especially when paired with a rehabilitation training program, multiple sessions are needed requiring multiple daily visits to the treatment facility. To overcome the challenges imposed by requiring daily clinic visits and to provide easier access to tDCS treatment, we have developed and tested a protocol to remotely supervise the delivery of tDCS in the home for participants with MS. Our protocol has extended training procedures and safety measures, including specially designed tDCS devices (delivering only one dose at a time when an ?unlock? code is provided by study staff) and headgear. We utilize a telemedicine platform to supervise all sessions through web-based videoconferencing. To determine whether individuals with MS would comply with a telemedicine protocol, we performed a study to determine the feasibility of our approach. A total of 10 treatment sessions were administered to patients using the telemedicine tDCS protocol. Over 80% of our participants complied with all procedures and experienced significant improvements in their fatigue and fatigability (measured by cognitive and physical tasks). The objective of this study is to confirm these findings in a large pilot trial in which MS participants will be assigned by chance to either an active or sham (simulated but inactive) tDCS treatment with the goal of increasing finger control (Specific Aim 1) and to adjust finger control to specific objects (Specific Aim 2). Participants diagnosed with progressive MS will be assigned by chance to 20 sessions over 4 weeks of active or sham tDCS sessions, each delivered for 20 minutes using our telemedicine platform through a study-provided computer. During the tDCS application, all participants will be directed to complete hand training exercises that make up an established rehabilitation program. We will also use a very innovative device to measure the rate of learning at each training session to closely understand how tDCS improves motor learning over time. All study completers who receive sham will be offered an additional 10 active sessions over an additional 2-week period. Measures of hand strength and function will be administered at baseline, study end (20 sessions), and, for those assigned to the sham, also at the end of the extension (30 sessions), along with other questionnaires. Applicability and Impact of Research: This work advances our understanding of tDCS as a treatment that is anticipated to be available as a low-cost option to many individuals living with
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Aug 07, 2017
- Source ID
- W81XWH1710320
Entities
People
- Leigh E Charvet
Organizations
- Grossman School of Medicine
- United States Army