tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis

NCT ID: NCT02538094

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-06-30

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.

Conditions

Multiple Sclerosis; Encephalitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham Stimulation First

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.

Group Type: SHAM_COMPARATOR

Sham Transcranial direct current stimulation

Intervention Type: DEVICE

Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus.

Anodal Transcranial direct current stimulation

Intervention Type: DEVICE

Delivery of transcranial direct current stimulation for 30 minutes.

Anodal Stimulation First

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

Group Type: EXPERIMENTAL

Sham Transcranial direct current stimulation

Intervention Type: DEVICE

Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus.

Anodal Transcranial direct current stimulation

Intervention Type: DEVICE

Delivery of transcranial direct current stimulation for 30 minutes.

Interventions

Sham Transcranial direct current stimulation

Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus.

Intervention Type: DEVICE

Anodal Transcranial direct current stimulation

Delivery of transcranial direct current stimulation for 30 minutes.

Intervention Type: DEVICE

Other Intervention Names

tDCS; tDCS

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tracy Vannorsdall, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins East Baltimore Campus; Medical Psychiatry department

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00033581

Identifier Type: -

Identifier Source: org_study_id