Nexstim NBS guided active rTMS
DeviceNexstim NBS guided active rTMS + standardized task-oriented therapy
NCT Number: NCT03010462
A prospective, multi-center, randomized, sham-controlled, 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 of the upper limb. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rancho Los Amigos National Rehabilitation Center, Downey, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nexstim NBS guided active rTMS + standardized task-oriented therapy
Nexstim NBS guided sham rTMS + standardized task-oriented therapy
Time frame: Change from baseline to 6 months after end of treatment.
Range 0 to 65. HIgher scores indicate better function. Minimal clinically important difference = change of 5 points or more on scale. Outcome measure = proportion of patients in treatment arm gaining at least 5 points on scale between baseline and 6 months after end of treatment.
Time frame: Change in score from baseline to 6 months after end of treatment
Range 0-65. HIgher scores indicate better function.
Time frame: Change in score from baseline to 6 months after end of treatment.
Range 0 to 57. Higher scores indicate better function.
Time frame: Change in score from baseline to 6 months after end of treatment
National Institute of Health Stroke Scale - Motor Arm. Range 0 to 4. Lower score indicates better function.
Time frame: Change in score from baseline to 6 months after end of treatment
EuroQoL - EQ-5D score. Range 0 to 100. HIgher numbers indicate better quality of life.
Nexstim Ltd
Industry
A Prospective, Multi-center, Randomized, Sham-controlled Trial to Determine the Therapeutic Effects of Navigation Guided 1 hz Rtms Administered to the Contralesional Hemisphere as Adjuvant to Task-oriented Rehabilitation in Patients With Ischemic Stroke
Acronym: E-FIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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