Trial Outcomes & Findings for Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI (NCT NCT03564496)
NCT ID: NCT03564496
Last Updated: 2024-01-17
Results Overview
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
Baseline Visit
Results posted on
2024-01-17
Participant Flow
Participant milestones
| Measure |
Healthy Controls
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
40
|
6
|
|
Overall Study
COMPLETED
|
26
|
36
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
0
|
Reasons for withdrawal
| Measure |
Healthy Controls
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Screen failure
|
0
|
3
|
0
|
Baseline Characteristics
Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=26 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
n=36 Participants
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
n=6 Participants
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
47 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
36 years
STANDARD_DEVIATION 14.54 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline VisitMeasured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Outcome measures
| Measure |
Healthy Controls
n=23 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
n=20 Participants
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
n=6 Participants
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Cerebral Metabolic Rate of Oxygen (CMRO2)
|
165.84 µmol/100g/min
Standard Deviation 25.32
|
128.3 µmol/100g/min
Standard Deviation 14
|
159.4 µmol/100g/min
Standard Deviation 21.8
|
PRIMARY outcome
Timeframe: Intermediate Visit (Month 1)Population: Only the Healthy Control subgroup and MS patients were evaluated for this outcome measure. The Healthy Control group was not evaluated because they did not receive any additional sessions after the first visit.
Measured via MRI. CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute)
Outcome measures
| Measure |
Healthy Controls
n=5 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
n=20 Participants
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Cerebral Metabolic Rate of Oxygen (CMRO2)
|
146.42 µmol/100g/min
Standard Deviation 27.71
|
140.59 µmol/100g/min
Standard Deviation 13.83
|
—
|
PRIMARY outcome
Timeframe: Baseline Visit (pre-tDCS, post-tDCS)NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS. tDCS will be administered in one visit and will last for approximately 15 minutes.
Outcome measures
| Measure |
Healthy Controls
n=23 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
n=20 Participants
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
n=5 Participants
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Neuronal Reactivity (NR)
|
9.84 percentage change of CMRO2
Standard Deviation 10.8
|
12.45 percentage change of CMRO2
Standard Deviation 13.8
|
15.61 percentage change of CMRO2
Standard Deviation 4.69
|
PRIMARY outcome
Timeframe: Baseline, Intermediate Visit (Month 1)Population: Only the Healthy Control subgroup and MS patients were evaluated for this outcome measure. The Healthy Control group was not evaluated because they did not receive any additional sessions after the first visit.
NR represents tDCS-induced global neural reactivity measured by CMRO2 levels in cells available to respond to neural stimuli. NR is measured as the percentage change of CMRO2 from no tDCS to real tDCS.
Outcome measures
| Measure |
Healthy Controls
n=20 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
n=5 Participants
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Neuronal Reactivity (NR)
|
4.32 percentage change of CMRO2
Standard Deviation 8.44
|
22.5 percentage change of CMRO2
Standard Deviation 6.88
|
—
|
SECONDARY outcome
Timeframe: Baseline VisitPopulation: Only MS patients were evaluated for this outcome measure. The Healthy Control group and Health Control subgroup were not administered the Neuro-QOL.
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
Outcome measures
| Measure |
Healthy Controls
n=31 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Quality of Life in Neurological Disorders (Neuro-QOL) Score
|
50.81 T-score
Standard Deviation 13.04
|
—
|
—
|
SECONDARY outcome
Timeframe: Intermediate Visit (Month 1)Population: Only MS patients were evaluated for this outcome measure. The Healthy Control group and Health Control subgroup were not administered the Neuro-QOL.
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
Outcome measures
| Measure |
Healthy Controls
n=26 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Quality of Life in Neurological Disorders (Neuro-QOL) Score
|
36.38 T-score
Standard Deviation 13.16
|
—
|
—
|
SECONDARY outcome
Timeframe: Final Visit (Month 4)Population: Only MS patients were evaluated for this outcome measure. The Healthy Control group and Health Control subgroup were not administered the Neuro-QOL.
36-item assessment of quality of life measures in participants with neurological disorders. This questionnaire will be administered to MS patients only. The raw score is the sum of responses; this score is transformed to a standardized T-score with a mean of 50 and SD of 10. A T-score of 60 indicates worse (undesirable) self-reported health.
Outcome measures
| Measure |
Healthy Controls
n=29 Participants
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Quality of Life in Neurological Disorders (Neuro-QOL) Score
|
39.12 T-score
Standard Deviation 12.65
|
—
|
—
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
MS Patients
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Healthy Control Subgroup
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Controls
n=26 participants at risk
Healthy Controls will be given approximately 15 minutes of active tDCS during MRI during the initial visit.
|
MS Patients
n=36 participants at risk
MS patients will be given approximately 15 minutes of active tDCS during MRI during the initial visit. After the first MRI visit, MS patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC. Around 3 months after the 20-session treatment, MS patients only will be asked to come to the clinic for neuropsychological assessments.
|
Healthy Control Subgroup
n=6 participants at risk
The Healthy Control subgroup will be given approximately 15 minutes of active tDCS during MRI during the initial visit. Participants in the healthy control subgroup will be given the option to have an additional 15 minutes of brain imaging, which will include 10 minutes of simultaneous tDCS at up to 4.0mA, added to the end of their baseline scan. After the first MRI visit, HC subgroup patients will receive remotely-supervised home tDCS treatment for a month to test the cumulative effects of tDCS. Participants will complete 20 x 2.0mA x 20 minute tDCS sessions paired with cognitive training over 4-week period (20 mins per day and weekend off) with electrodes placed to target the bilateral DLPFC.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Tingling
|
30.8%
8/26 • 4 months
Systematic assessment through self-reported questionnaires.
|
38.9%
14/36 • 4 months
Systematic assessment through self-reported questionnaires.
|
0.00%
0/6 • 4 months
Systematic assessment through self-reported questionnaires.
|
|
Skin and subcutaneous tissue disorders
Itching
|
23.1%
6/26 • 4 months
Systematic assessment through self-reported questionnaires.
|
11.1%
4/36 • 4 months
Systematic assessment through self-reported questionnaires.
|
0.00%
0/6 • 4 months
Systematic assessment through self-reported questionnaires.
|
|
Skin and subcutaneous tissue disorders
Warmth Sensation under the electrode
|
23.1%
6/26 • 4 months
Systematic assessment through self-reported questionnaires.
|
25.0%
9/36 • 4 months
Systematic assessment through self-reported questionnaires.
|
0.00%
0/6 • 4 months
Systematic assessment through self-reported questionnaires.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place