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tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis

Primary Purpose

Multiple Sclerosis, Encephalitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham Transcranial direct current stimulation
Anodal Transcranial direct current stimulation
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Cognitive Enhancement, tDCS, stimulation, MS, Multiple Sclerosis, Encephalitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins East Baltimore Campus; Medical Psychiatry department

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Stimulation First

Anodal Stimulation First

Arm 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.

Transcranial direct current stimulation using Anodal stimulation first over the area of interest and then Sham Stimulation second.

Outcomes

Primary Outcome Measures

Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores
Change in performance on an individual cognitive test measure raw score from the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery tests (i.e. Paced Auditory Serial Addition Test scores). Change scores range from -120 to + 120. Positive change scores reflect improvement at the end of the intervention relative to baseline. Negative change scores reflect decline at the end of the intervention relative to baseline.

Secondary Outcome Measures

Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores
Fatigue was measured via changes in self-reported fatigue on the Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) total score over the course of active and sham tDCS. Change scores range from -84 to + 84. Positive change values reflect increased symptom burden at the end of the intervention relative to baseline. Negative change scores reflect reduced symptom burden at the end of the intervention relative to baseline.

Full Information

First Posted
March 25, 2015
Last Updated
April 3, 2020
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02538094
Brief Title
tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis
Official Title
Transcranial Direct Current Stimulation and Cognition in Adults With Multiple Sclerosis or Encephalitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Encephalitis
Keywords
Cognitive Enhancement, tDCS, stimulation, MS, Multiple Sclerosis, Encephalitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Stimulation First
Arm Type
Sham Comparator
Arm 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.
Arm Title
Anodal Stimulation First
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation using Anodal stimulation first over the area of interest and then Sham Stimulation second.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus.
Intervention Type
Device
Intervention Name(s)
Anodal Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Delivery of transcranial direct current stimulation for 30 minutes.
Primary Outcome Measure Information:
Title
Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores
Description
Change in performance on an individual cognitive test measure raw score from the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery tests (i.e. Paced Auditory Serial Addition Test scores). Change scores range from -120 to + 120. Positive change scores reflect improvement at the end of the intervention relative to baseline. Negative change scores reflect decline at the end of the intervention relative to baseline.
Time Frame
Assessed at beginning and end of a 5-day treatment week
Secondary Outcome Measure Information:
Title
Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores
Description
Fatigue was measured via changes in self-reported fatigue on the Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) total score over the course of active and sham tDCS. Change scores range from -84 to + 84. Positive change values reflect increased symptom burden at the end of the intervention relative to baseline. Negative change scores reflect reduced symptom burden at the end of the intervention relative to baseline.
Time Frame
Assessed at beginning and end of a 5-day treatment week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy Vannorsdall, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins East Baltimore Campus; Medical Psychiatry department
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis

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