Pilot Study of Transcranial Direct Current Stimulation (tDCS)

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Device: Sham Transcranial Direct Current Stimulation
Device: Transcranial Direct Current Stimulation (tDCS)
Behavioral: Cognitive Training Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02746705
15-01189

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

Transcranial Direct Current Stimulation (tDCS)
Active Comparator group
Treatment:
Behavioral: Cognitive Training Program
Device: Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Sham Comparator group
Treatment:
Behavioral: Cognitive Training Program
Device: Sham Transcranial Direct Current Stimulation

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems