Chronic Stroke, Fatigue, Stroke, Stroke Sequelae
Conditions
Brief summary
Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.
Interventions
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
DEVICEsham stimulation
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center of Neuromodulation for Rehabilitation
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women of any race or ethnicity * 35-80 years of age * 6+ months post-stroke * Have clinically present fatigue for 6 months * Able to walk 10m unassisted
Exclusion criteria
* Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples) * Inability to understand and provide written informed consent * Multiple strokes on opposite hemispheres * Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, and dementia) * Severe hypertension * Cerebellar or brainstem strokes/lesions * Concurrent depression and/or anxiety disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Severity Scale (FSS) Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Assessment Scale (FAS) | Baseline, post-intervention (2-weeks) | Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Real | Total | Sham |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 6 | 62 years STANDARD_DEVIATION 9 | 63 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 3 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change in Fatigue Severity Scale (FSS) Score
Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue
Time frame: Baseline, post-intervention (2-weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real | Change in Fatigue Severity Scale (FSS) Score | -0.4 units on a scale | Standard Deviation 0.9 |
| Sham | Change in Fatigue Severity Scale (FSS) Score | 0.2 units on a scale | Standard Deviation 0.4 |
Secondary
Change in Fatigue Assessment Scale (FAS)
Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue
Time frame: Baseline, post-intervention (2-weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real | Change in Fatigue Assessment Scale (FAS) | -7 score on a scale | Standard Deviation 8 |
| Sham | Change in Fatigue Assessment Scale (FAS) | -4 score on a scale | Standard Deviation 10 |