Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial

NCT03010462 | Completed Results DMC FDA Device

• 1 other identifier: NX103391
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Stroke; rTMS; Motor rehabilitation

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Fugl-Meyer Score

  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.

  Change from baseline to 6 months after end of treatment.

Secondary Outcomes (4)

• Upper Extremity Fugl-Meyer Score

  Change in score from baseline to 6 months after end of treatment

• Arm-Research Action Test (ARAT)

  Change in score from baseline to 6 months after end of treatment.

• NIH Stroke Scale (NIHSS)

  Change in score from baseline to 6 months after end of treatment

• Quality of Life Assessment: EQ-5D

  Change in score from baseline to 6 months after end of treatment

Study Arms (2)

Active

ACTIVE COMPARATOR

Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation

Device: Nexstim NBS guided active rTMS

Control

SHAM COMPARATOR

Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation

Device: Nexstim NBS guided sham rTMS

Interventions

Nexstim NBS guided active rTMS DEVICE

Nexstim NBS guided active rTMS + standardized task-oriented therapy

Active

Nexstim NBS guided sham rTMS DEVICE

Nexstim NBS guided sham rTMS + standardized task-oriented therapy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• An ischemic stroke suffered 3-12 months prior to the study
• No other known brain abnormalities by history;
• A one-sided stroke resulting in upper extremity paresis
• A Chedoke-McMaster Stroke Assessment arm stage and hand stage of 3-6 for the affected limb

You may not qualify if:

• Implanted metallic parts of implanted electronic devices, including pacemakers, defibrillators, or implant medication pump;
• Pregnant or trying to become pregnant; Lack of pregnancy established in females of child-bearing potential by a negative urine pregnancy test at screening.
• Active alcohol abuse, illicit drug use or drug abuse or significant mental illness
• Patients suffering from depression as measured by a score of \>10 on the Patient Health Questionnaire (PHQ9). For clarity, patients diagnosed with depression which is controlled with stable anti-depressive medication and in whom PHQ9 is \<10 are eligible to participate in the trial.
• History of epilepsy, defined as at least two unprovoked seizures occurring greater than 24 hours apart or diagnosis of an epilepsy syndrome, OR a seizure within the last 12 months.
• Any condition that would prevent the subject from giving voluntary informed consent;
• An implanted brain stimulator;
• Any metal in head with the exception of dental work or any ferromagnetic metal -elsewhere in the body;
• Enrolled or plans to enroll in an interventional trial during this study;
• Scalp wounds or infections;
• Claustrophobia precluding MRI;
• A fixed contraction deformity in the affected limb that would prevent normal dexterity if patient were neurologically intact;
• Excessive spasticity as indicated by the Modified Ashworth Spasticity (MAS) Scale \>2/4 in either elbow flexors, wrist flexors or finger flexors of the affected limb;
• Premorbid (retrospective) modified Rankin Scale (mRS) score ≥2 of any aetiology;
• A concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification \> 3), or other major medical condition,

Sponsors & Collaborators

• Nexstim Ltd: lead

Study Sites (5)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Burke Medical Research Institute, Weill Cornell Neurology

White Plains, New York, 10605, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• Edwards DJ, Liu CY, Dunning K, Fregni F, Laine J, Leiby BE, Rogers LM, Harvey RL. Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial. Stroke. 2023 Sep;54(9):2254-2264. doi: 10.1161/STROKEAHA.123.043164. Epub 2023 Aug 14.

  PMID: 37577801 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Nexstim Plc

jarmo.laine@nexstim.com

+358927271710

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: March 1, 2017
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: April 26, 2021
• Results First Posted: April 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)