Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: NBS-guided rTMS; Device: Sham rTMS; Procedure: Task oriented rehabilitation

• Registration Number: NCT02089464
• Lead Sponsor: Nexstim Ltd

Brief Summary

A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Study Start: 2014-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Disposition First Submitted: 2017-09-13
• Disposition First Submitted QC: 2017-09-19
• Disposition First Posted: 2017-09-27
• Status Verified: 2020-08
• Results First Submitted: 2020-08-04
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-09-01
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBS-rTMS + task-oriented rehabilitation	Task oriented rehabilitation	NBS-guided rTMS + task-oriented rehabilitation
NBS-rTMS + task-oriented rehabilitation	NBS-guided rTMS	NBS-guided rTMS + task-oriented rehabilitation
Sham rTMS + task-oriented rehabilitation	Sham rTMS	Sham rTMS + task-oriented rehabilitation
Sham rTMS + task-oriented rehabilitation	Task oriented rehabilitation	Sham rTMS + task-oriented rehabilitation

Primary Outcome Measures

Name	Time	Method
Upper Extremity Fugl-Meyer Score	Baseline - 6 months post-treatment	Number of Participants with Improvement in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-treatment equal or exceeding the Minimal Clinically Important Difference (MCID) of 5 points (MCID).

Secondary Outcome Measures

Name	Time	Method
Quality of Life Assessment: EuroQol EQ-5D Scale	Baseline - 6 months post-treatment	The EuroQoL EQ-5D is a visual analog scale scale from 0 (minimum) to 100 (maximum) assessing quality of life. Higher values indicate better quality of life.
Arm-Research Action Test (ARAT)	Baseline - 6 months post-treatment	Scale minimum 0, maximum 57. Greater values indicate better motor function.
Chedoke-McMaster Stroke Assessment (CMSA)	Baseline - 6 months post-treatment	Scale minimum 1, maximum 7. Higher values indicate better motor function of hand.
Wolf Motor Function Test	Baseline - 6 months post-treatment	Time in seconds to perform test tasks. Shorter time indicates better motor function.
NIH Stroke Scale (NIHSS)	Baseline - 6 months post-treatment	Scale is a measure of neurological functioning, with higher scores reflecting greater deficit (minimum 0,maximum 42)
Stroke Impact Scale (SIS)	Baseline - 6 months post-treatment	Score used to detect the consequences of stroke on physical functioning and activities of daily living. The SIS-16 is a 16 item survey that inquires about daily tasks performed over the previous 2 weeks. Scale minimum 16, maximum 80. Higher values indicate better function
Patient Health Questionnaire (PHQ9)	Baseline - 6 months post-treatment	The possible presence and severity of depression will be assessed using the Patient Health Questionnaire (PHQ9). PHQ9 is a scale with a minimum value 0 and maximum of 27. Higher values indicate more depressed mood

Trial Locations

Locations (12)

Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States

TIRR Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

Indiana University Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Shepherd Rehabilitation Center; 🇺🇸 Atlanta, Georgia, United States

Columbia Cornell New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Burke Medical Research Institute, Weill Cornell Neurology; 🇺🇸 White Plains, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States