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Pilot Study of Transcranial Direct Current Stimulation (tDCS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation
Cognitive Training Program
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation (tDCS)

Sham Transcranial Direct Current Stimulation (tDCS)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 4, 2016
Last Updated
April 28, 2020
Sponsor
NYU Langone Health
Collaborators
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT02746705
Brief Title
Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Official Title
Pilot Study of Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation (tDCS)
Arm Type
Active Comparator
Arm Title
Sham Transcranial Direct Current Stimulation (tDCS)
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
Soterix 1x1 tDCS mini-CT
Intervention Description
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
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Description
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
Behavioral
Intervention Name(s)
Cognitive Training Program
Primary Outcome Measure Information:
Title
The Number of Participants Completing at Least 80% of the Targeted Sessions.
Description
80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
Time Frame
Four Weeks
Title
Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
Description
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.
Time Frame
Baseline, Four Weeks
Secondary Outcome Measure Information:
Title
Change in Score on Modified Fatigue Impact Scale (MFIS)
Description
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.
Time Frame
Baseline, 4 Weeks
Title
Change in Score of CogState Brief Battery (CBB)
Description
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.
Time Frame
Baseline, 4 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30522497
Citation
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.
Results Reference
derived

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Pilot Study of Transcranial Direct Current Stimulation (tDCS)

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