Stroke
Conditions
Brief summary
The study aims to identify neural locus critical for dual-task walking (walking and talking) in individuals with stroke. To achieve this aim, the investigators apply repetitive transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the effects of brain stimulation on dual-task walking speed.
Detailed description
This study will enroll 12 individuals with a stroke at least 6 months ago. Participants will be tested across 3 sessions and each session will be approximately 1 week apart from each other. During testing, participants will be asked to walk under two conditions: single- and dual-task conditions. Under the single-task condition, participants walk on a instrumented mat such that their gait performance will be captured. Under the dual-task condition, participants walk on the mat while performing a counting backward task. The walking assessment is followed by a 12 minute non-invasive brain stimulation using high frequency rTMS. Another walking assessment will be conducted right after the brain stimulation session. High frequency rTMS will be applied to different neural loci, namely primary motor cortex (M1), supplementary motor area (SMA), and dorsolateral prefrontal cortex (DLPFC). The walking speed under two different conditions will be compared before and after brain stimulation to different neural loci.
Interventions
DEVICEhigh frequency rTMS
Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex (M1), supplementary motor area (SMA) and dorsolateral prefrontal cortex (DLPFC) at different sessions. Walking performance is evaluated before and after the brain stimulation.
Sponsors
Texas Woman's University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age above 18 years 2. Diagnosis of Left hemispheric stroke at least 6 months ago 3. First time stroke OR complete gait recovery from prior stroke 4. Able to walk independently for at least 10 meters with or without walking aids 5. Have at least minimal movements (\> 5 degree of motion) at the affected ankle 6. Score \> 26 on Mini Mental State Exam (MMSE) 7. Ability to participate in the informed consent process
Exclusion criteria
1. Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis 2. Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis) 3. Unstable clinical conditions 4. Non-ambulatory prior to onset of stroke 5. History of significant head trauma 6. Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip 7. Metal implantation in the oral cavity, head/neck area and lower extremity 8. Pregnancy 9. History of seizures or unexplained loss of consciousness 10. Immediate family member with epilepsy 11. Use of seizure threshold lowering medicine 12. Current abuse of alcohol or drugs 13. Anticipated inability to complete the study 14. History of psychiatric illness requiring medication control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Speed | before and 10 minutes after the non-invasive brain stimulation | gait speed in m/s will be captured using GaitRite gait assessment walkway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Step Lengths | before and 10 minutes after the non-invasive brain stimulation | Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway |
| Change in Single Support Times | before and 10 minutes after the non-invasive brain stimulation | Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway |
| Change in Counting Task Performance | before and 10 minutes after the non-invasive brain stimulation | number of correct responses in counting backward task |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Dallas Fort Worth metro area. Recruitment started in October 2016 and last participant was enrolled in Oct 2018.
Participants by arm
| Arm | Count |
|---|---|
| High Frequency rTMS High frequency rTMS will be applied to different neural loci based on the randomized sessions.
high frequency rTMS: Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | High Frequency rTMS | — |
|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 9.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change in Gait Speed
gait speed in m/s will be captured using GaitRite gait assessment walkway
Time frame: before and 10 minutes after the non-invasive brain stimulation
Population: Changes in gait speed under the dual-task conditions were compared across the 3 visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Frequency rTMS | Change in Gait Speed | Primary motor cortex (M1) | -0.49 m/s | Standard Error 1.66 |
| High Frequency rTMS | Change in Gait Speed | Supplementary motor area (SMA) | -0.80 m/s | Standard Error 2.64 |
| High Frequency rTMS | Change in Gait Speed | Dorsolateral prefrontal cortex (DLPFC) | 5.49 m/s | Standard Error 2.19 |
Secondary
Change in Counting Task Performance
number of correct responses in counting backward task
Time frame: before and 10 minutes after the non-invasive brain stimulation
Population: number of correct response under the dual-task conditions before and after the rTMS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Frequency rTMS | Change in Counting Task Performance | Primary motor cortex (M1) | -0.18 number of correct responses | Standard Error 0.83 |
| High Frequency rTMS | Change in Counting Task Performance | Supplementary motor area (SMA) | -0.59 number of correct responses | Standard Error 0.66 |
| High Frequency rTMS | Change in Counting Task Performance | Dorsolateral prefrontal cortex (DLPFC) | -0.65 number of correct responses | Standard Error 0.74 |
Secondary
Change in Single Support Times
Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway
Time frame: before and 10 minutes after the non-invasive brain stimulation
Population: Changes in right (R) and left (L) single support time after repetitive transcranial magnetic stimulation (rTMS) applied to dorsolateral prefrontal cortex (DLPFC)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Frequency rTMS | Change in Single Support Times | changes in R single support after rTMS to DLPFC | 0.63 percentage of gait cycle | Standard Error 1.87 |
| High Frequency rTMS | Change in Single Support Times | changes in L single support after rTMS | 2.50 percentage of gait cycle | Standard Error 1.11 |
Secondary
Change in Step Lengths
Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway
Time frame: before and 10 minutes after the non-invasive brain stimulation
Population: Changes in right (R) and left (L) step lengths after repetitive transcranial magnetic stimulation (rTMS) applied to dorsolateral prefrontal cortex (DLPFC)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Frequency rTMS | Change in Step Lengths | Changes in R step length after rTMS to DLPFC | 2.24 centimeter (cm) | Standard Error 1.02 |
| High Frequency rTMS | Change in Step Lengths | Changes in L step length after rTMS to DLPFC | 1.38 centimeter (cm) | Standard Error 1.13 |