Electric Field Navigated 1hz Rtms for Post-stroke Motor Recovery Trial
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Neurology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/15/2019 |
Start Date: | March 1, 2017 |
End Date: | August 15, 2018 |
A Prospective, Multi-center, 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 Stroke
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.
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.
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 <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;
- 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.
We found this trial at
5
sites
345 E Superior St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 238-1000

Principal Investigator: Richard L Harvey, MD
Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
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300 1st Avenue
Boston, Massachusetts 02129
Boston, Massachusetts 02129
617-952-5000

Principal Investigator: Felipe Fregni, MD
Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000

Principal Investigator: Kari Dunning, PhD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Downey, California 90242
Principal Investigator: Charles Y Liu, MD
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White Plains, New York 10605
Principal Investigator: Dylan Edwards, PhD
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