NCT03441334

Brief Summary

The study will enroll 5 individuals post-stroke to examine the feasibility and efficacy of a high frequency repetitive transcranial magnetic stimulation (rTMS) combined with body weight supported treadmill training.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

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
9 months until next milestone

Study Start

First participant enrolled

November 12, 2018

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2018

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

14 days

First QC Date

February 9, 2018

Results QC Date

October 18, 2022

Last Update Submit

May 3, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in Walking Speed

    Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance.

    10 weeks

Secondary Outcomes (4)

  • Change in Quality of Life

    10 weeks

  • Change in Motor Function

    10 weeks

  • Change in Cortical Excitability

    10 weeks

  • Change in Walking Endurance

    10 weeks

Study Arms (2)

High Frequency rTMS

EXPERIMENTAL

The High Frequency rTMS group will receive real repetitive transcranial magnetic stimulation (rTMS) in 5Hz at 90% of resting motor threshold delivered to the bilateral motor areas via a figure of 8 air-filmed coil. The stimulation is structured as 24 10-second trains with a inter-train interval of 30 second.

Device: High Frequency rTMS

Sham rTMS

SHAM COMPARATOR

The Sham rTMS group will receive the same protocol but delivered via a sham coil which generates the same auditory and cutaneous feedback as the real stimulation. However, there will be no active stimulation.

Device: Sham rTMS

Interventions

High Frequency rTMSDEVICE

Participants in the intervention group will receive 1200 stimuli at the intensity of 90% of resting motor threshold via an air-filmed coil placed on the vertex. The stimulation will be delivered across 24 sessions (in 10 weeks). Right after each session, participants will receive a 45-minute structured body weight supported treadmill training.

High Frequency rTMS
Sham rTMSDEVICE

Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training.

Sham rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • \< 2 months post stroke at the time of enrollment
  • first time stroke:
  • able to walk \> 25 feet with or without assistive device and with no more than moderate assistance:
  • able to follow 1-step commands
  • able to communicate verbally

You may not qualify if:

  • severe medical problems (e.g. recent cardiac infarct, heart failure, cancer)
  • presence of conditions that could affect gait training (e.g. amputation, severe arthritis)
  • bilateral stroke
  • non-ambulatory prior to stroke
  • BMI \> 40
  • any contraindications to TMS (e.g. history of seizure, cardiac pacemaker, metal or magnetic implants)
  • pregnant or potentially to be pregnant

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, Assistant Professor
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
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
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

November 12, 2018

Primary Completion

November 26, 2018

Study Completion

November 26, 2018

Last Updated

May 6, 2023

Results First Posted

May 6, 2023

Record last verified: 2023-05

Locations

US(1)