Trial Outcomes & Findings for Cerebellar tDCS and Balance Training in PwMS (NCT NCT04391023)
NCT ID: NCT04391023
Last Updated: 2024-06-18
Results Overview
The BBS is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify PwMS with a high fall risk.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
24 hours, 2 weeks, and 4 weeks post-intervention
Results posted on
2024-06-18
Participant Flow
No participants were assigned to the 2 mA tDCS group
Participant milestones
| Measure |
Sham tDCS
The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA.
Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
|
4 mA tDCS
The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Sham tDCS
The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA.
Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
|
4 mA tDCS
The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Cerebellar tDCS and Balance Training in PwMS
Baseline characteristics by cohort
| Measure |
Sham tDCS
n=9 Participants
The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA.
Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
|
4 mA tDCS
n=9 Participants
The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.57 years
STANDARD_DEVIATION 11.04 • n=99 Participants
|
50.57 years
STANDARD_DEVIATION 14.89 • n=107 Participants
|
50.57 years
STANDARD_DEVIATION 11.86 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Fatigue Severity Scale
|
4.48 units on a scale
STANDARD_DEVIATION 1.68 • n=99 Participants
|
3.14 units on a scale
STANDARD_DEVIATION 1.36 • n=107 Participants
|
4.17 units on a scale
STANDARD_DEVIATION 1.50 • n=206 Participants
|
|
Functional Gait Assessment
|
24.71 units on a scale
STANDARD_DEVIATION 4.86 • n=99 Participants
|
23.14 units on a scale
STANDARD_DEVIATION 9.04 • n=107 Participants
|
23.93 units on a scale
STANDARD_DEVIATION 6.77 • n=206 Participants
|
|
Berg Balance Scale
|
53 units on a scale
STANDARD_DEVIATION 4.93 • n=99 Participants
|
50 units on a scale
STANDARD_DEVIATION 11.56 • n=107 Participants
|
51.73 units on a scale
STANDARD_DEVIATION 8.41 • n=206 Participants
|
|
Six Minute Walk Test
|
431.51 meters
STANDARD_DEVIATION 86.09 • n=99 Participants
|
481.30 meters
STANDARD_DEVIATION 35.73 • n=107 Participants
|
460.72 meters
STANDARD_DEVIATION 70.40 • n=206 Participants
|
|
Timed Up and Go
|
8.15 seconds
STANDARD_DEVIATION 1.55 • n=99 Participants
|
8.78 seconds
STANDARD_DEVIATION 3.54 • n=107 Participants
|
8.42 seconds
STANDARD_DEVIATION 2.55 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hours, 2 weeks, and 4 weeks post-interventionThe BBS is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify PwMS with a high fall risk.
Outcome measures
| Measure |
4 mA tDCS
n=7 Participants
The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
|
Sham tDCS
n=7 Participants
The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA.
Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
|
|---|---|---|
|
Score on the Berg Balance Scale
24 hours post-intervention
|
51.43 units on a scale
Standard Deviation 9.11
|
54.43 units on a scale
Standard Deviation 2.37
|
|
Score on the Berg Balance Scale
2-weeks post-intervention
|
50.33 units on a scale
Standard Deviation 10.21
|
54.67 units on a scale
Standard Deviation 2.07
|
|
Score on the Berg Balance Scale
4-weeks post-intervention
|
51.17 units on a scale
Standard Deviation 9.93
|
54.29 units on a scale
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: 24 hours, 2 weeks, and 4 weeks post-interventionThe TUG measures the time it takes for the participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Two trials were completed and the reported score is the average time between the two trials. A higher number means it took the participant more time to complete the task (i.e., worse performance).
Outcome measures
| Measure |
4 mA tDCS
n=7 Participants
The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
|
Sham tDCS
n=7 Participants
The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA.
Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
|
|---|---|---|
|
Time to Complete the Timed Up and Go Test (TUG)
24 hours post-intervention
|
7.47 seconds
Standard Deviation 3.78
|
7.81 seconds
Standard Deviation 1.66
|
|
Time to Complete the Timed Up and Go Test (TUG)
2-week post-intervention
|
6.99 seconds
Standard Deviation 3.34
|
7.55 seconds
Standard Deviation 1.43
|
|
Time to Complete the Timed Up and Go Test (TUG)
4-weeks post-intervention
|
6.88 seconds
Standard Deviation 3.10
|
7.10 seconds
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: 24 hours, 2 weeks, and 4 weeks post-interventionSubjects performed the 6MWT in a cordoned-off hallway with two symbols on the ground, placed 30 meters apart. Subjects were instructed to walk as far as possible between the marks for 6 minutes, walking around each symbol like a cone. Higher scores indicate more distance walked (i.e., better performance).
Outcome measures
| Measure |
4 mA tDCS
n=7 Participants
The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
|
Sham tDCS
n=7 Participants
The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA.
Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
|
|---|---|---|
|
Time to Complete the Six Minute Walk Test (6MWT)
24 hours post-intervention
|
523.31 meters
Standard Deviation 44.70
|
464.04 meters
Standard Deviation 107.68
|
|
Time to Complete the Six Minute Walk Test (6MWT)
2-weeks post-intervention
|
542.15 meters
Standard Deviation 91.86
|
479.33 meters
Standard Deviation 137.44
|
|
Time to Complete the Six Minute Walk Test (6MWT)
4-weeks post-intervention
|
545.03 meters
Standard Deviation 104.95
|
487.44 meters
Standard Deviation 114.10
|
SECONDARY outcome
Timeframe: 24 hours, 2-weeks, and 4-weeks post-interventionThe FSS consists of nine statements used to assess perceived fatigability. Subjects are asked to rate how much they felt a statement applied to them, on a 7-point scale (low value = does not apply, high value = high agreement with the statement). The questionnaire is scored by calculating the average response to the statements. Therefore, the scores will range from 1 to 7 (1 = low fatigue, 7 = high fatigue). A score ≥ 4 indicates a clinically significant level of fatigue.
Outcome measures
| Measure |
4 mA tDCS
n=7 Participants
The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
4 mA Transcranial Direct Current Stimulation: tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
|
Sham tDCS
n=7 Participants
The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA.
Sham Transcranial Direct Current Stimulation (tDCS): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance Training: The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
|
|---|---|---|
|
Score on the Fatigue Severity Scale (FSS)
24 hours post-intervention
|
3.62 units on a scale
Standard Deviation 2.11
|
4.21 units on a scale
Standard Deviation 1.38
|
|
Score on the Fatigue Severity Scale (FSS)
2-weeks post-intervention
|
4.39 units on a scale
Standard Deviation 1.31
|
3.81 units on a scale
Standard Deviation 1.52
|
|
Score on the Fatigue Severity Scale (FSS)
4-weeks post-intervention
|
3.80 units on a scale
Standard Deviation 1.64
|
3.60 units on a scale
Standard Deviation 1.51
|
Adverse Events
Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 mA tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place