Overview

This trial has been completed.

Condition stroke
Treatments nbs-guided rtms, sham rtms
Sponsor Nexstim Ltd
Start date April 2014
End date May 2016
Trial size 199 participants
Trial identifier NCT02089464, NX92325

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator, outcomes assessor
Arm
(Active Comparator)
NBS-guided rTMS + task-oriented rehabilitation
nbs-guided rtms Nexstim
(Sham Comparator)
Sham rTMS + task-oriented rehabilitation
sham rtms

Primary Outcomes

Measure
Upper extremity Fugl-Meyer score
time frame: Baseline - 6 months post-treatment

Secondary Outcomes

Measure
Arm-Research Action Test (ARAT)
time frame: Baseline - 6 months post-treatment
Wolf Motor Function Test
time frame: Baseline - 6 months post-treatment
NIH Stroke Scale (NIHSS)
time frame: Baseline - 6 months post-treatment
Chedoke-McMaster Stroke Assessment (CMSA)
time frame: Baseline - 6 months post-treatment
Stroke Impact Scale (SIS)
time frame: Baseline - 6 months post-treatment
Patient Health Questionnaire (PHQ9)
time frame: Baseline - 6 months post-treatment
Quality of life assessment: EQ-5D
time frame: Baseline - 6 months post-treatment

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria : - ≥ 18 years of age - An ischemic or hemorrhagic 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;i - 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.

Additional Information

Official title Pivotal Phase III, Prospective, Multicenter, Double Blinded, 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 or Hemorrhagic Stroke
Principal investigator Richard L Harvey, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Nexstim Ltd.