Trial Outcomes & Findings for Non-invasive Brain Stimulation (NIBS) and Dual-task Walking After Stroke (NCT NCT03442868)

Results Overview

gait speed in m/s will be captured using GaitRite gait assessment walkway

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

before and 10 minutes after the non-invasive brain stimulation

Results posted on

2020-11-20

Participant Flow

Participants were recruited from Dallas Fort Worth metro area. Recruitment started in October 2016 and last participant was enrolled in Oct 2018.

Participant milestones

Participant milestones
Measure	High Frequency Repetitive Transcranial Magnetic Stimulation (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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Frequency rTMS n=15 Participants 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.
Age, Continuous	57.7 years STANDARD_DEVIATION 9.7 • n=15 Participants
Sex: Female, Male Female	5 Participants n=15 Participants
Sex: Female, Male Male	10 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants

PRIMARY outcome

Timeframe: 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.

gait speed in m/s will be captured using GaitRite gait assessment walkway

Outcome measures

Outcome measures
Measure	High Frequency rTMS n=15 Participants 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.
Change in Gait Speed Primary motor cortex (M1)	-0.49 m/s Standard Error 1.66
Change in Gait Speed Supplementary motor area (SMA)	-0.80 m/s Standard Error 2.64
Change in Gait Speed Dorsolateral prefrontal cortex (DLPFC)	5.49 m/s Standard Error 2.19

SECONDARY outcome

Timeframe: 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)

Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway

Outcome measures

Outcome measures
Measure	High Frequency rTMS n=15 Participants 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.
Change in Step Lengths Changes in R step length after rTMS to DLPFC	2.24 centimeter (cm) Standard Error 1.02
Change in Step Lengths Changes in L step length after rTMS to DLPFC	1.38 centimeter (cm) Standard Error 1.13

SECONDARY outcome

Timeframe: 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)

Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway

Outcome measures

Outcome measures
Measure	High Frequency rTMS n=15 Participants 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.
Change in Single Support Times changes in R single support after rTMS to DLPFC	0.63 percentage of gait cycle Standard Error 1.87
Change in Single Support Times changes in L single support after rTMS	2.50 percentage of gait cycle Standard Error 1.11

SECONDARY outcome

Timeframe: 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

number of correct responses in counting backward task

Outcome measures

Outcome measures
Measure	High Frequency rTMS n=15 Participants 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.
Change in Counting Task Performance Primary motor cortex (M1)	-0.18 number of correct responses Standard Error 0.83
Change in Counting Task Performance Supplementary motor area (SMA)	-0.59 number of correct responses Standard Error 0.66
Change in Counting Task Performance Dorsolateral prefrontal cortex (DLPFC)	-0.65 number of correct responses Standard Error 0.74

Adverse Events

High Frequency rTMS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High Frequency rTMS n=15 participants at risk 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.
General disorders Headache	6.7% 1/15 • Number of events 1 • 3 weeks
Infections and infestations Infection	6.7% 1/15 • Number of events 1 • 3 weeks

Additional Information

Hui-Ting Goh

Texas Woman's University

Phone: 2146897723

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place