Pilot Study of Transcranial Direct Current Stimulation (tDCS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02746705|
Recruitment Status : Completed
First Posted : April 21, 2016
Results First Posted : May 8, 2020
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: Transcranial Direct Current Stimulation (tDCS) Device: Sham Transcranial Direct Current Stimulation Behavioral: Cognitive Training Program||Not Applicable|
Transcranial direct current stimulation (tDCS) has been demonstrated to:
- successfully treat fatigue in adults with MS, and
- improve learning ability and other aspects of cognitive functioning in healthy controls and in participants with a range of medical disorders.
Cognitive impairment in MS remains a major treatment challenge and a trial of tDCS combined with a cognitive training program to treat MS-related cognitive impairment is warranted. However, one barrier for the study of tDCS has been the need for the participant to travel to the study site for each tDCS administration. To address this issue, the biomedical company Soterix, has recently designed a remote-delivery tDCS device designed for use in clinical trials. Therefore, the primary goal of this study is to establish a protocol for remotely-supervised in-home tDCS delivery for studies with MS participants. Established safety and feasibility of remotely-supervised tDCS delivery will facilitate the next steps of larger controlled trials, in both MS as well as other conditions, to determine efficacy and appropriate real-world use.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Pilot Study of Transcranial Direct Current Stimulation (tDCS)|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
|Active Comparator: Transcranial Direct Current Stimulation (tDCS)||
Device: Transcranial Direct Current Stimulation (tDCS)
tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
Other Name: Soterix 1x1 tDCS mini-CT
Behavioral: Cognitive Training Program
|Sham Comparator: Sham Transcranial Direct Current Stimulation (tDCS)||
Device: Sham Transcranial Direct Current Stimulation
During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
Behavioral: Cognitive Training Program
- The Number of Participants Completing at Least 80% of the Targeted Sessions. [ Time Frame: Four Weeks ]80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
- Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS) [ Time Frame: Baseline, Four Weeks ]
BICAMS comprises two tests, the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test-Revised (BVMT-R).
Scoring for SDMT involves summing the number of correct substitutions within the 90 second interval (max = 110. The higher the score, the better).
Visual/spatial memory is assessed in BICAMS using the BVMTR. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12 (the higher the score, the better).
The total score range for BICAMS is 0-122. The higher the score, the better.
- Change in Score on Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline, 4 Weeks ]MFIS consists of 21 statements. The number that best indicates how often fatigue has affected the participant in the manner described during the past 4 weeks is circled. Answer choices include: 0 - never, 1 - rarely, 2 - sometimes, 3 - often, 4 - almost always. The total score ranges from 0 to 84. The higher the number, the more frequently fatigue impacted the participant during the past 4 weeks.
- Change in Score of CogState Brief Battery (CBB) [ Time Frame: Baseline, 4 Week ]CBB is a brief, computer-administered cognitive test battery that requires approximately 10 minutes for administration. If the CBB score falls between -10 to +10, it is considered normal. CogState scoring is such that 0 could be considered as performing in the average range for that subtest compared to people of similar age. A negative score means that the performance was lower than average, and a positive score means the performance was higher than average. Higher positive scores (for instance 0.2 becoming 0.5) may indicate slightly better performance and higher negative scores (for instance, -0.4 becoming -0.8) may indicate slightly worsening performance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746705
|United States, New York|
|New York University Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Leigh Charvet||NYU Langone Medical Center|