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N/A N=199 Randomized Triple-blind Treatment

Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial

Stroke

Enrolled (actual)
199
Serious AEs
9.0%
Results posted
Sep 2020
Primary outcome: Primary: Upper Extremity Fugl-Meyer Score — 88; 43 Participants — p=0.76

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
NBS-guided rTMS (Device); Sham rTMS (Device); Task oriented rehabilitation (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Nexstim Ltd
Primary completion
May 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Upper Extremity Fugl-Meyer Score
88; 43 0.76
SECONDARY
Arm-Research Action Test (ARAT)
5.0; 5.0 0.80
SECONDARY
Wolf Motor Function Test
-9.0; -10.6 0.55
SECONDARY
NIH Stroke Scale (NIHSS)
-0.4; -0.7 0.14
SECONDARY
Chedoke-McMaster Stroke Assessment (CMSA)
0.5; 0.5 0.14
SECONDARY
Stroke Impact Scale (SIS)
6.7; 8.7
SECONDARY
Patient Health Questionnaire (PHQ9)
-0.2; 0.0 0.95
SECONDARY
Quality of Life Assessment: EuroQol EQ-5D Scale
7.7; 6.9 0.96

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.

Eligibility Criteria

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 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02089464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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