Transcranial Direct Current Stimulation and Cognition in Adults With Multiple Sclerosis or Encephalitis

CompletedNot a drug-phase studyMS (type not specified)NCT02538094

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Anodal Transcranial direct current stimulation

Placebo

  • Sham Transcranial direct current stimulation

Results by group

Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores

Assessed at beginning and end of a 5-day treatment week

GroupValueIntervalNumber analysed
Sham tDCS-1.20 score on a scale6.26 (Standard Deviation)5
Active Anodal tDCS-0.33 score on a scale9.42 (Standard Deviation)6

Sham tDCS

-1.2

Active Anodal tDCS

-0.33

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Sham tDCS60 (0.0%)0
Active Anodal tDCS70 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores

    Assessed at beginning and end of a 5-day treatment week

    Thinking and memory

Other measures (1)

  • Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores

    Assessed at beginning and end of a 5-day treatment week

    Fatigue

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Sept 2014

    2. Main results due

      Jun 2019

    3. Finished

      Jun 2019

    4. Results posted

      Apr 2020

    Assembled by software from public sources.