Multiple SclerosisNCT02746705
Pilot Study of Transcranial Direct Current Stimulation (tDCS)
A study testing Transcranial Direct Current Stimulation (tDCS) and Cognitive Training Program in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS) and Cognitive Training Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation, Cognitive Training Program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called Soterix 1x1 tDCS mini-CT
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
Sham Transcranial Direct Current StimulationDevice
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 ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Active comparator | Not described Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Cognitive Training Program |
| Sham Transcranial Direct Current Stimulation (tDCS) | Sham comparator | Not described Receives: Device: Sham Transcranial Direct Current Stimulation; Behavioral: Cognitive Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Completing at Least 80% of the Targeted Sessions.
80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
Measured: Four Weeks
Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
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.
Measured: Baseline, Four Weeks
Secondary outcomes (2)
Change in Score on Modified Fatigue Impact Scale (MFIS)
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.
Measured: Baseline, 4 Weeks
Change in Score of CogState Brief Battery (CBB)
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.
Measured: Baseline, 4 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Stony Brook University
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746705
- Sponsor's protocol ID
- 15-01189
- Status last verified
- Apr 2020
- First submitted
- 4 Apr 2016
- Last updated
- 8 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 30522497
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT02746705
- Acronym / sponsor ID
- 15-01189
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Stony Brook University
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 8 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Cognitive Training Program |
| Sham Transcranial Direct Current Stimulation (tDCS) | Sham comparator | Device: Sham Transcranial Direct Current Stimulation, Behavioral: Cognitive Training Program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: Soterix 1x1 tDCS mini-CTtDCS 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 | Device | Transcranial Direct Current Stimulation (tDCS) |
| Sham Transcranial Direct Current StimulationDuring 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. | Device | Sham Transcranial Direct Current Stimulation (tDCS) |
| Cognitive Training Program | Behavioural | Sham Transcranial Direct Current Stimulation (tDCS), Transcranial Direct Current Stimulation (tDCS) |
Primary outcome
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.
2 secondary outcomes
Change in Score on Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline, 4 Weeks
Change in Score of CogState Brief Battery (CBB)
Time frame: Baseline, 4 Week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30522497Dobbs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Charvet principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) and Cognitive Training Program in people with Multiple Sclerosis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Completing at Least 80% of the Targeted Sessions. (time frame: Four Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020; AzTrials last refreshed its copy on 27 Oct 2026.