Stroke
Conditions
Keywords
adult, chronic stroke
Brief summary
This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.
Interventions
COMBINATION_PRODUCTanodal transcranial direct current stimulation (a-tDCS)
Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.
Sponsors
American Heart Association
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 21 and 90 years 2. Medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment 3. MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract 4. Hemiparesis involving the lower extremity (Fulg-Meyer LE motor test) 5. No passive range of motion limitation in bilateral hips and knees 6. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less 7. Visual acuity can be corrected by glasses or contact lens to 20/20 8. Able to walk independently with/without assistant devices for 10 meters 9. Able to maintain standing position without any assistance \> 30 sec (Short Physical Performance Battery) 10. Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24
Exclusion criteria
1. Pregnant women 2. MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors 3. Have any metal implants, cardiac pacemakers, or history of seizures 4. Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training 5. Any vestibular dysfunction or unstable angina 6. Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning | Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training | Stepping motor control will be quantified by the time (seconds) that each participant takes to initiate a forward step onto a visual target displayed on the wall screen. |
| Mean change from baseline in brain neuronal activations after five sessions of brain stimulation combined with visuomotor stepping learning | Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training | The neuronal activations will be quantified by peak-to-peak electrical signals detected by surface electromyographic (EMG) electrodes on leg muscles after transcranial magnetic stimulations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in lower extremity (LE) motor function after five sessions of brain stimulation combined with visuomotor stepping learning | Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training | LE motor function will be quantified by Fugl-Meyer LE motor test, Short Physical Performance Battery (SPPB), and gait speed (meters/second) during ground walking tests. |
| Mean change from baseline in brain neuronal network activations after five sessions of brain stimulation combined with visuomotor stepping learning | Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training | The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes |
Countries
United States
Contacts
Primary ContactShih-Chiao Tseng, PT, PhD
Outcome results
None listed