NCT03442868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

February 9, 2018

Results QC Date

October 6, 2020

Last Update Submit

November 19, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in Gait Speed

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

    before and 10 minutes after the non-invasive brain stimulation

Secondary Outcomes (3)

  • Change in Step Lengths

    before and 10 minutes after the non-invasive brain stimulation

  • Change in Single Support Times

    before and 10 minutes after the non-invasive brain stimulation

  • Change in Counting Task Performance

    before and 10 minutes after the non-invasive brain stimulation

Study Arms (1)

High frequency rTMS

EXPERIMENTAL

High frequency rTMS will be applied to different neural loci based on the randomized sessions.

Device: high frequency rTMS

Interventions

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.

High frequency rTMS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Hui-Ting Goh
Organization
Texas Woman's University
HGoh1@twu.edu
2146897723

Study Officials

  • Hui-Ting Goh

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 22, 2018

Study Start

October 19, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 20, 2020

Results First Posted

November 20, 2020

Record last verified: 2020-11

Locations

US(1)