N/A
N=60
Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03010462 ↗Enrolled (actual)
60
Serious AEs
15.5%
Results posted
Apr 2021
Primary outcome: Primary: Upper Extremity Fugl-Meyer Score — 18; 14 Participants — p=0.62
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nexstim NBS guided active rTMS (Device); Nexstim NBS guided sham rTMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nexstim Ltd
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Upper Extremity Fugl-Meyer Score |
5.17; 5.00 | 0.46 |
| SECONDARY Upper Extremity Fugl-Meyer Score |
5.17; 5.00 | 0.46 |
| SECONDARY Arm-Research Action Test (ARAT) |
4.93; 5.68 | 0.54 |
| SECONDARY NIH Stroke Scale (NIHSS) |
-0.62; -0.50 | 0.59 |
| SECONDARY Quality of Life Assessment: EQ-5D |
9.86; 8.96 | 0.70 |
Summary
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03010462). 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.