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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.
Participants enrolled into this study may be asked to do the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Anodal Stimulation First | Experimental | Transcranial direct current stimulation using Anodal stimulation first over the area of interest and then Sham Stimulation second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Transcranial direct current stimulation | Device | Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy Vannorsdall, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins East Baltimore Campus; Medical Psychiatry department | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham tDCS First | Participants received sham tDCS first and then active anodal tDCS after washout. |
| FG001 | Active Anodal tDCS First | Participants received active anodal tDCS first and then sham tDCS after washout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (5 Days Per Participant) |
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| Washout (4 Weeks) |
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| Intervention 2 (5 Days Per Participant) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at beginning and end of a 5-day treatment week |
|
Up to 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus |
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Recruitment was not sufficient to permit planned statistical analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tracy Vannorsdall | Johns Hopkins University SOM | 4105023701 | TVannor1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Mar 5, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2016 | Mar 5, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D004660 | Encephalitis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Anodal Transcranial direct current stimulation | Device | Delivery of transcranial direct current stimulation for 30 minutes. |
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| Assessed at beginning and end of a 5-day treatment week |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Paced Auditory Serial Addition Test | The Paced Auditory Serial Addition Test (PASAT) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. PASAT scores range from 0 to 120 with higher scores reflecting better performance. | Mean | Standard Deviation | score on a scale |
|
| Multidimensional Fatigue Symptom Inventory 30-item short form score | The Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) is an instrument for assessing fatigue. MFSI-SF scores range from 0 to 84, with higher values reflecting greater fatigue. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Active Anodal tDCS | Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes. |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Assessed at beginning and end of a 5-day treatment week |
|
|
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Active Anodal tDCS | Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |