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tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis

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Johns Hopkins University

Status

Completed

Conditions

Multiple Sclerosis
Encephalitis

Treatments

Device: Sham Transcranial direct current stimulation
Device: Anodal Transcranial direct current stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02538094
IRB00033581

Details and patient eligibility

About

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities in individuals with multiple sclerosis (MS) or encephalitis. Participants will be asked to come in daily for two full weeks during which time participants will undergo cognitive testing and Magnetic Resonance Imaging (MRI) brain scans. In this research, a very weak electrical current is administered to the surface of the scalp while participants complete cognitive tasks. The investigators' aim is to find out whether tDCS will improve task performance in adults with multiple sclerosis or encephalitis.

Full description

Participants enrolled into this study may be asked to do the following:

  • Come to the investigators' testing office at the Johns Hopkins Hospital where the tDCS equipment is located for 10 study visits.
  • Grant permission for the researchers to view medical records associated with the participant's diagnosis of multiple sclerosis or encephalitis (if applicable) and general state of health.
  • Complete a questionnaire and provide a health history in order to verify eligibility to participate and be able to safely undergo the experimental procedures.
  • Complete several computerized, written, and/or aural tasks (i.e., saying words out loud) that assess different cognitive functions such as attention, memory, language, or processing speed.
  • Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) for 30 minutes.
  • Participate in several study conditions. The exact conditions and the order will be randomized. That is, the conditions and order will vary by chance (like the flip of a coin). Under some conditions, the participant might receive active stimulation (tDCS) and under other conditions, the participant might receive placebo (or sham) stimulation. Placebo stimulation is similar to active tDCS but lasts only a few seconds. However, all groups will wear the electrodes for the same length of time to prevent the participant from knowing whether participants are receiving active tDCS or sham stimulation. The study doctor and research staff will know which group the participant is in.
  • Permission to audio and/or video-tape test sessions for later scoring and observation. These tapes will not be viewed by anyone not affiliated with the study without the participant's consent.
  • Have structural, resting-state and functional Magnetic Resonance Imaging scans as a part of the study.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of multiple sclerosis or encephalitis
  • Over the age of 18

Exclusion criteria

  • A diagnosis of schizophrenia bipolar disorder
  • Beck Depression Inventory-II scores over 20
  • Mini Mental Exam below 24
  • Any uncontrolled seizure disorder
  • Any implanted metal device or hearing aids
  • Use of medication shown to interact with tDCS effectiveness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

7 participants in 2 patient groups

Sham Stimulation First
Sham Comparator group
Description:
Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS first and then Anodal Stimulation second.
Treatment:
Device: Anodal Transcranial direct current stimulation
Device: Sham Transcranial direct current stimulation
Anodal Stimulation First
Experimental group
Description:
Transcranial direct current stimulation using Anodal stimulation first over the area of interest and then Sham Stimulation second.
Treatment:
Device: Anodal Transcranial direct current stimulation
Device: Sham Transcranial direct current stimulation

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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