Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial (E-FIT)

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Nexstim NBS guided active rTMS; Device: Nexstim NBS guided sham rTMS

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital
  • New York
    • White Plains, New York, United States, 10605
      • Burke Medical Research Institute, Weill Cornell Neurology
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 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

Exclusion Criteria:

• 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;
• Previous stroke with residual deficits (TIAs not a reason for exclusion);
• 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,
• Confirmed or suspected lower-limb fracture preventing mobilization, patients requiring palliative care
• Patients planning to undergo any other occupational therapy during the 6 week active treatment period of the trial (see section 5.2 for study schedule) than what is provided in the study
• A recent injection of botulinium toxin to the affected upper limb in the last 3 months, or the need of an injection of botulinum toxin anytime during the study period and follow up.
• A recent injection of phenol to the affected upper limb in the last 6 months, or the need of an injection of phenol anytime during the study period and follow up.
• Ataxia as measured by a score > 1 on item 7 (limb ataxia) of the NIH stroke scale.
• Severe sensory deficits as measured by a score of 2 on item 8 of the NIH stroke scale.
• Severe aphasia as measured by a score of > 2 on item 9 (best language) of the NIH stroke scale.
• Severe neglect as measured by a score of 2 on item 11 (extinction and inattention) of the NIH stroke scale.
• Patients unable to comprehend or follow verbal commands
• Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition
• A Mini mental status exam (MMSE) <25.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Intervention: Device: NBS-guided rTMS + task-oriented rehabilitation	Device: Nexstim NBS guided active rTMS; Nexstim NBS guided active rTMS + standardized task-oriented therapy
Sham Comparator: Control; Intervention: Device: NBS-guided Sham rTMS + task-oriented rehabilitation	Device: Nexstim NBS guided sham rTMS; Nexstim NBS guided sham rTMS + standardized task-oriented therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Fugl-Meyer Score	Range 0-65. HIgher scores indicate better function.	Change in score from baseline to 6 months after end of treatment
Arm-Research Action Test (ARAT)	Range 0 to 57. Higher scores indicate better function.	Change in score from baseline to 6 months after end of treatment.
NIH Stroke Scale (NIHSS)	National Institute of Health Stroke Scale - Motor Arm. Range 0 to 4. Lower score indicates better function.	Change in score from baseline to 6 months after end of treatment
Quality of Life Assessment: EQ-5D	EuroQoL - EQ-5D score. Range 0 to 100. HIgher numbers indicate better quality of life.	Change in score from baseline to 6 months after end of treatment

Collaborators and Investigators

• Sponsor: Nexstim Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 15, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; rTMS; Motor rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NX103391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No