Status:
TERMINATED
Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity
Lead Sponsor:
PathMaker Neurosystems Inc.
Collaborating Sponsors:
Spaulding Rehabilitation Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Muscle Spasticity
Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a multi-center, randomized, double-blind (patient and evaluator), sham-controlled study to be conducted in stroke patients with upper-extremity spasticity. The main objectives of this study ar...
Detailed Description
Stroke is the fifth leading cause of death in the U.S. and a leading cause of serious long-term disability. There are over 7.5 million patients in the U.S. living with stroke, and an estimated 795,000...
Eligibility Criteria
Inclusion
- ≥ 18 to \< 85 years of age
- First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior to study enrollment
- At least 6 weeks of stable UE spasticity symptoms (as confirmed by medical history) with a baseline Modified Ashworth Scale (MAS) score of 1+ to 3 (on the 0, 1, 1+, 2, 3, 4 scale), inclusive, in the wrist flexor muscles
- Willing to forgo botulinum toxin, phenol or alcohol injections into the muscles of the limb targeted for the study treatment; intrathecal baclofen; digitalis, and morphine for the subject's duration in the study
- Willing to forgo upper extremity physical and occupational therapy for the duration of the study (lower extremity PT and OT are allowed)
- Willing to maintain current regiment for oral spasticity medication(s) and neurotransmitter medication(s) for the subject's duration in the study
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with appropriate clinician)
Exclusion
- Fixed contractures or profound muscle atrophy of the target spastic wrist to be treated
- Change in antispastic oral medication (baclofen, clonidine, benzodiazepine, dantrolene, gabapentin, tizanidine) in the 2 months prior to study enrollment
- Use of digitalis, morphine, or intrathecal pump in the week prior to study enrollment
- Prior botulinum toxin injection(s) into the muscles of the limb targeted for the study treatment within 12 weeks of study enrollment
- Prior phenol or alcohol injections into the muscles of the limb targeted for the study treatment within 6 months of study enrollment
- Prior surgery for spasticity in the target muscle group
- Prior transcranial or trans-spinal direct current stimulation for any reason
- Presence of potential tsDCS risk factors:
- Damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
- Lack of sensory perception at the stimulation sites
- Presence of an electrically, magnetically, or mechanically activated implant (including cardiac pacemaker) or any other electrically sensitive support system with the exception of loop recorders
- Ferrous metal in the path of the current flow (jewelry must be removed during stimulation)
- Past history of epileptic seizures or unexplained spells of loss of consciousness during the previous 36 months
- Other neurological conditions involving CNS impairment, including Parkinson's Disease, Multiple Sclerosis, and Spinal Cord Injury
- Any medical condition that would prevent the subject from being able to participate in the clinical outcome measures
- Previous participating in a study involving the application of tsDCS
- Pregnancy in women (as determined by pregnancy test in pre-menopausal women)
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04742257
Start Date
March 4 2022
End Date
June 30 2024
Last Update
August 15 2024
Active Locations (2)
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1
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02138
2
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02114