tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis

NCT02538094 | Completed Results

• 1 other identifier: IRB00033581
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Encephalitis

Keywords

Cognitive Enhancement; tDCS; stimulation; MS; Multiple Sclerosis; Encephalitis

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (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

Study Arms (2)

Sham Stimulation First

SHAM COMPARATOR

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.

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

Anodal Stimulation First

EXPERIMENTAL

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

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

Interventions

Sham Transcranial direct current stimulation DEVICE

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

Also known as: tDCS

Anodal Stimulation First; Sham Stimulation First

Anodal Transcranial direct current stimulation DEVICE

Delivery of transcranial direct current stimulation for 30 minutes.

Also known as: tDCS

Anodal Stimulation First; Sham Stimulation First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins East Baltimore Campus; Medical Psychiatry department

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Encephalitis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Recruitment was not sufficient to permit planned statistical analyses.

Results Point of Contact

• Title: Dr. Tracy Vannorsdall
• Organization: Johns Hopkins University SOM

TVannor1@jhmi.edu

4105023701

Study Officials

• Tracy Vannorsdall, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2014
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)