StrokeNCT03442868

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

A study testing high frequency rTMS in people with Stroke, run by Texas Woman's University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: high frequency rTMS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2016to 31 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age above 18 years
Diagnosis of Left hemispheric stroke at least 6 months ago
First time stroke OR complete gait recovery from prior stroke
Able to walk independently for at least 10 meters with or without walking aids
Have at least minimal movements (> 5 degree of motion) at the affected ankle
Score > 26 on Mini Mental State Exam (MMSE)
Ability to participate in the informed consent process

Who cannot join

Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis
Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis)
Unstable clinical conditions
Non-ambulatory prior to onset of stroke
History of significant head trauma
Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip

Show all 14Show fewer

Metal implantation in the oral cavity, head/neck area and lower extremity
Pregnancy
History of seizures or unexplained loss of consciousness
Immediate family member with epilepsy
Use of seizure threshold lowering medicine
Current abuse of alcohol or drugs
Anticipated inability to complete the study
History of psychiatric illness requiring medication control

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas Woman's University
Dallas, Texas, 75235

Other trials in United States

About this study

Official title: Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A Repetitive Transcranial Magnetic Stimulation (rTMS) Study

Read the 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.

Conditions: Stroke
Being tested: high frequency rTMS
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high frequency rTMSDevice
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.

Study groups in NCT03442868
Study group	Role	What they receive
High frequency rTMS	Experimental	High frequency rTMS will be applied to different neural loci based on the randomized sessions. Receives: Device: high frequency rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Gait Speed
gait speed in m/s will be captured using GaitRite gait assessment walkway
Measured: before and 10 minutes after the non-invasive brain stimulation

Secondary outcomes (3)

Change in Step Lengths
Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway
Measured: before and 10 minutes after the non-invasive brain stimulation
Change in Single Support Times
Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway
Measured: before and 10 minutes after the non-invasive brain stimulation
Change in Counting Task Performance
number of correct responses in counting backward task
Measured: before and 10 minutes after the non-invasive brain stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 201631 Dec 2018

First posted22 Feb 2018
Study start19 Oct 2016
Primary completion31 Dec 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03442868
Sponsor's protocol ID: 19219
Status last verified: Nov 2020
First submitted: 9 Feb 2018
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
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Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
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A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A Repetitive Transcranial Magnetic Stimulation (rTMS) Study
ClinicalTrials.gov ID: NCT03442868
Acronym / sponsor ID: 19219
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Texas Woman's UniversityUniversity, hospital or other
Study start: 19 Oct 2016 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 22 Feb 2018 (actual)
Results: Posted 20 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
High frequency rTMS	Experimental	Device: high frequency rTMSHigh frequency rTMS will be applied to different neural loci based on the randomized sessions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age above 18 years
Diagnosis of Left hemispheric stroke at least 6 months ago
First time stroke OR complete gait recovery from prior stroke
Able to walk independently for at least 10 meters with or without walking aids
Have at least minimal movements (> 5 degree of motion) at the affected ankle

Key exclusion criteria (14 listed)

Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis
Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis)
Unstable clinical conditions
Non-ambulatory prior to onset of stroke
History of significant head trauma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high frequency rTMSParticipants 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.	Device	High frequency rTMS

Primary outcome

Change in Gait Speed
Time frame: before and 10 minutes after the non-invasive brain stimulation
gait speed in m/s will be captured using GaitRite gait assessment walkway

3 secondary outcomes

Change in Step Lengths
Time frame: before and 10 minutes after the non-invasive brain stimulation
Change in Single Support Times
Time frame: before and 10 minutes after the non-invasive brain stimulation
Change in Counting Task Performance
Time frame: before and 10 minutes after the non-invasive brain stimulation

Results and safety

Results posted to the registry on 20 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS)	15	15

Primary outcome: Change in Gait Speed

Time frame: before and 10 minutes after the non-invasive brain stimulation. Mean (Standard Error). Unit: m/s

Measure	High Frequency rTMS n = 15
Primary motor cortex (M1)	-0.49 (1.66)
Supplementary motor area (SMA)	-0.80 (2.64)
Dorsolateral prefrontal cortex (DLPFC)	5.49 (2.19)

Population analysed: Changes in gait speed under the dual-task conditions were compared across the 3 visits.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Frequency rTMS	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Stroke

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hui-Ting Goh principal investigator

Texas Woman's University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing high frequency rTMS in people with Stroke, run by Texas Woman's University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gait Speed (time frame: before and 10 minutes after the non-invasive brain stimulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03442868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.