Overview

This trial is active, not recruiting.

Condition stroke
Treatments nbs-guided rtms, sham rtms
Sponsor Nexstim Ltd
Start date April 2014
End date May 2016
Trial size 200 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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
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

Male or female 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 September 2016.
Information provided to ClinicalTrials.gov by Nexstim Ltd.