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Completed

NCT Number: NCT03010462

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Los Amigos National Rehabilitation Center, Downey, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nexstim NBS guided active rTMS

Device

Nexstim NBS guided active rTMS + standardized task-oriented therapy

Nexstim NBS guided sham rTMS

Device

Nexstim NBS guided sham rTMS + standardized task-oriented therapy

Primary outcomes

  1. Upper Extremity Fugl-Meyer Score

    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.

Secondary outcomes

  1. Upper Extremity Fugl-Meyer Score

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

    Range 0-65. HIgher scores indicate better function.

  2. Arm-Research Action Test (ARAT)

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

    Range 0 to 57. Higher scores indicate better function.

  3. NIH Stroke Scale (NIHSS)

    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.

  4. Quality of Life Assessment: EQ-5D

    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.

Sponsors and collaborators

Lead sponsor

Nexstim Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2017
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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