Multiple Sclerosis, Encephalitis
Conditions
Keywords
Cognitive Enhancement, tDCS, stimulation, MS, Multiple Sclerosis, Encephalitis
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.
Interventions
DEVICESham Transcranial direct current stimulation
Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus.
Delivery of transcranial direct current stimulation for 30 minutes.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Transcranial direct current stimulation using Anodal stimulation over the area of interest or sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intervention 1 (5 Days Per Participant) | Withdrawal by Subject | 0 | 1 |
| Washout (4 Weeks) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 51.29 years STANDARD_DEVIATION 11.16 |
| Multidimensional Fatigue Symptom Inventory 30-item short form score | 55.43 score on a scale STANDARD_DEVIATION 23.06 |
| Paced Auditory Serial Addition Test | 76.29 score on a scale STANDARD_DEVIATION 25.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Assessed at beginning and end of a 5-day treatment week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham tDCS | Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores | -1.20 score on a scale | Standard Deviation 6.26 |
| Active Anodal tDCS | Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores | -0.33 score on a scale | Standard Deviation 9.42 |
Secondary
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.
Time frame: Assessed at beginning and end of a 5-day treatment week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham tDCS | Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores | -7.40 score on a scale | Standard Deviation 8.08 |
| Active Anodal tDCS | Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores | -15.0 score on a scale | Standard Deviation 18.23 |