Trial Outcomes & Findings for Post-stroke Fatigue, Inflammation, tDCS (NCT NCT05330988)
NCT ID: NCT05330988
Last Updated: 2024-12-10
Results Overview
Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline, post-intervention (2-weeks)
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
Real
Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs.
anodal transcranial direct current stimulation (a-tDCS): The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
Sham
Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs.
sham stimulation: The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-stroke Fatigue, Inflammation, tDCS
Baseline characteristics by cohort
| Measure |
Real
n=6 Participants
Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs.
anodal transcranial direct current stimulation (a-tDCS): The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
Sham
n=6 Participants
Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs.
sham stimulation: The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 6 • n=5 Participants
|
63 years
STANDARD_DEVIATION 12 • n=7 Participants
|
62 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-intervention (2-weeks)Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue
Outcome measures
| Measure |
Real
n=6 Participants
Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs.
anodal transcranial direct current stimulation (a-tDCS): The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
Sham
n=6 Participants
Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs.
sham stimulation: The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
|---|---|---|
|
Change in Fatigue Severity Scale (FSS) Score
|
-0.4 units on a scale
Standard Deviation 0.9
|
0.2 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (2-weeks)Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue
Outcome measures
| Measure |
Real
n=6 Participants
Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs.
anodal transcranial direct current stimulation (a-tDCS): The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
Sham
n=6 Participants
Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs.
sham stimulation: The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
|
|---|---|---|
|
Change in Fatigue Assessment Scale (FAS)
|
-7 score on a scale
Standard Deviation 8
|
-4 score on a scale
Standard Deviation 10
|
Adverse Events
Real
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham
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