NCT03442868

Non-invasive Brain Stimulation (NIBS) and Dual-task Walking After Stroke

Completed NA Results posted Last updated 20 November 2020

What this trial tests

NA trial testing high frequency rTMS in Stroke in 15 participants. Completed in 31 December 2018.

Timeline

19 October 2016

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	Texas Woman's University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	19 October 2016
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across United States

Drugs / interventions tested

• high frequency rTMS

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Texas Woman's University

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Gait Speed Primary · before and 10 minutes after the non-invasive brain stimulation

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

Primary motor cortex (M1)

Group	Value	95% CI
High Frequency rTMS	-0.49	± 1.66

Supplementary motor area (SMA)

Group	Value	95% CI
High Frequency rTMS	-0.80	± 2.64

Dorsolateral prefrontal cortex (DLPFC)

Group	Value	95% CI
High Frequency rTMS	5.49	± 2.19

Change in Step Lengths Secondary · before and 10 minutes after the non-invasive brain stimulation

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

Changes in R step length after rTMS to DLPFC

Group	Value	95% CI
High Frequency rTMS	2.24	± 1.02

Changes in L step length after rTMS to DLPFC

Group	Value	95% CI
High Frequency rTMS	1.38	± 1.13

Change in Single Support Times Secondary · 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

changes in R single support after rTMS to DLPFC

Group	Value	95% CI
High Frequency rTMS	0.63	± 1.87

changes in L single support after rTMS

Group	Value	95% CI
High Frequency rTMS	2.50	± 1.11

Change in Counting Task Performance Secondary · before and 10 minutes after the non-invasive brain stimulation

number of correct responses in counting backward task

Primary motor cortex (M1)

Group	Value	95% CI
High Frequency rTMS	-0.18	± 0.83

Supplementary motor area (SMA)

Group	Value	95% CI
High Frequency rTMS	-0.59	± 0.66

Dorsolateral prefrontal cortex (DLPFC)

Group	Value	95% CI
High Frequency rTMS	-0.65	± 0.74

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High Frequency rTMS

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (2 terms — click to expand)

Reaction	System	High Frequency rTMS
Headache	General disorders	—
Infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT03442868 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.