N/A
N=199
Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02089464 ↗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
| Outcome | Result | p-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.
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.