Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) for Post COVID-19 Fatigue (NCT NCT04876417)
NCT ID: NCT04876417
Last Updated: 2024-05-01
Results Overview
Fatigue Questionnaire (1 to 5-point scale x 10 questions for a total score range of 0 to 50) where a low value indicates less fatigued (better outcome) and a high value indicates more fatigued (worse outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
through study completion, an average of 8 weeks
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
tDCS and Fatigue
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Fatigue
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
tDCS and Non-fatigue
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Non-fatigue
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
10
|
10
|
|
Overall Study
COMPLETED
|
22
|
19
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
0
|
0
|
Reasons for withdrawal
| Measure |
tDCS and Fatigue
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Fatigue
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
tDCS and Non-fatigue
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Non-fatigue
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
0
|
0
|
Baseline Characteristics
Transcranial Direct Current Stimulation (tDCS) for Post COVID-19 Fatigue
Baseline characteristics by cohort
| Measure |
tDCS and Fatigue
n=22 Participants
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Fatigue
n=19 Participants
This group will receive the sham form of tDCS.
Sham Transcranial Direct Current Stimulation
|
tDCS and Non-fatigue
n=10 Participants
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Non-fatigue
n=10 Participants
This group will receive the sham form of tDCS.
Sham Transcranial Direct Current Stimulation
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
37.23 Years
STANDARD_DEVIATION 11.71 • n=99 Participants
|
36.74 Years
STANDARD_DEVIATION 14.37 • n=107 Participants
|
30.13 Years
STANDARD_DEVIATION 10.02 • n=206 Participants
|
30.13 Years
STANDARD_DEVIATION 10.02 • n=7 Participants
|
34.30 Years
STANDARD_DEVIATION 14.13 • n=31 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 8 weeksFatigue Questionnaire (1 to 5-point scale x 10 questions for a total score range of 0 to 50) where a low value indicates less fatigued (better outcome) and a high value indicates more fatigued (worse outcome)
Outcome measures
| Measure |
tDCS and Fatigue
n=22 Participants
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Fatigue
n=19 Participants
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
tDCS and Non-fatigue
n=10 Participants
This group will receive the active form of tDCS. Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Non-fatigue
n=10 Participants
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
|---|---|---|---|---|
|
Fatigue Assessment Scale (FAS)
|
31.32 Total score (1 to 5 point scale)
Standard Deviation 8.41
|
28.42 Total score (1 to 5 point scale)
Standard Deviation 6.41
|
14.90 Total score (1 to 5 point scale)
Standard Deviation 3.63
|
15.3 Total score (1 to 5 point scale)
Standard Deviation 4.57
|
PRIMARY outcome
Timeframe: through study completion, an average of 8 weeksFatigue Questionnaire (1 to 7 point scale x 9 questions for a total score range of 0 to 63) with a low value indicating less severe fatigue (better outcome) and a high value indicating more severe fatigue (worse outcome)
Outcome measures
| Measure |
tDCS and Fatigue
n=22 Participants
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Fatigue
n=19 Participants
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
tDCS and Non-fatigue
n=10 Participants
This group will receive the active form of tDCS. Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Non-fatigue
n=10 Participants
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
|---|---|---|---|---|
|
Fatigue Severity Scale (FSS)
|
5.08 Total score (1-7 point scale)
Standard Deviation 1.60
|
4.73 Total score (1-7 point scale)
Standard Deviation 1.14
|
2.13 Total score (1-7 point scale)
Standard Deviation 0.61
|
1.98 Total score (1-7 point scale)
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: through study completion, an average of 8 weeksDistance in meters will be measured in six minutes
Outcome measures
| Measure |
tDCS and Fatigue
n=22 Participants
This group will receive the active form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Fatigue
n=19 Participants
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
tDCS and Non-fatigue
n=10 Participants
This group will receive the active form of tDCS. Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
Sham and Non-fatigue
n=10 Participants
This group will receive the sham form of tDCS.
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
|
|---|---|---|---|---|
|
6-minute Walk Test
|
435.4 meters
Standard Deviation 70.47
|
460.69 meters
Standard Deviation 58.67
|
489.01 meters
Standard Deviation 68.11
|
451.38 meters
Standard Deviation 65.86
|
Adverse Events
tDCS and Fatigue
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham and Fatigue
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tDCs and Non-fatigued
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham and Non-fatigued
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
Thorsten Rudroff, PhD, Associate Professor
University of Iowa
Phone: (319) 467-0363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place