Pilot Study of Transcranial Direct Current Stimulation (tDCS)

NCT ID: NCT02746705

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-09-30

Brief Summary

This study will test the tolerability and preliminary efficacy of transcranial direct current stimulation (tDCS) combined with a cognitive training program, remotely-delivered using a telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will evaluate the efficacy of tDCS to evaluate two of the most debilitating symptoms of MS: cognitive impairment and fatigue.

Detailed Description

Transcranial direct current stimulation (tDCS) has been demonstrated to:

1. successfully treat fatigue in adults with MS, and

2. 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transcranial Direct Current Stimulation (tDCS)

Group Type: ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

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

Cognitive Training Program

Intervention Type: BEHAVIORAL

Sham Transcranial Direct Current Stimulation (tDCS)

Group Type: SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

Cognitive Training Program

Intervention Type: BEHAVIORAL

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Cognitive Training Program

Intervention Type: BEHAVIORAL

Other Intervention Names

Soterix 1x1 tDCS mini-CT

Eligibility Criteria

Inclusion Criteria

• Ages 18-70
• Definite MS diagnosis, all subtypes [95]
• MS-related changes in cognitive functioning
• A score of 6.5 or lesson the Expanded
• Disability Status Scale (EDSS) OR more than 6.5 with proxy
• Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or ethernet cable)
• Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/)
• Adequate home facilities (enough space, access to quiet and distraction free area)
• Able to commit to the two-week period of training sessions with baseline and follow-up visits.
• Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria

• Visual, auditory and motor deficits that would prevent full ability to understand study instructions or operate the tDCS device or study laptop, as judged by treating neurologist or study staff
• Relapse or steroid use in previous month
• History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
• Primary psychiatric disorder that would influence ability to participate
• History of seizures or seizure disorder
• Current chronic headaches or migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded.
• History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
• Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
• Treatment for a communicable skin disorder currently or over the past 12 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Charvet

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

New York University Langone Medical Center

New York, New York, United States

Countries

United States

References

Dobbs B, Pawlak N, Biagioni M, Agarwal S, Shaw M, Pilloni G, Bikson M, Datta A, Charvet L. Generalizing remotely supervised transcranial direct current stimulation (tDCS): feasibility and benefit in Parkinson's disease. J Neuroeng Rehabil. 2018 Dec 7;15(1):114. doi: 10.1186/s12984-018-0457-9.

Reference Type: DERIVED

PMID: 30522497 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-01189

Identifier Type: -

Identifier Source: org_study_id