Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity

NCT04742257 | Terminated FDA Device

• 2 other identifiers: PMN-0031U44NS104138
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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 are to evaluate the performance and safety of the MyoRegulator® device in active- versus sham-treated patients after 5 consecutive days of treatment. The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation for the treatment of muscle spasticity.

Conditions

Muscle Spasticity; Stroke

Keywords

stroke rehabilitation; spasticity; neuromodulation; trans-spinal direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Change in wrist flexor spasticity following 5 days of treatment compared to baseline as measured by the Modified Ashworth Scale score

  The Modified Ashworth Scale is a validated clinical measurement for the evaluation of spasticity after stroke.

  Up to 8 weeks post-treatment

Secondary Outcomes (6)

• Change in Modified Ashworth Scale total upper limb score following 5 days of treatment as compared to baseline

  Up to 8 weeks post-treatment

• Change in Upper-Extremity Fugl-Meyer motor domain score following 5 days of treatment as compared to baseline

  Up to 8 weeks post-treatment

• Change in Modified Tardieu Scale total upper limb score following 5 days of treatment as compared to baseline

  Up to 8 weeks post-treatment

• Improvement in subject's self-assessment of their spasticity following 5 days of treatment as compared to baseline

  Up to 8 weeks post-treatment

• Improvement in spasticity as assessed by an investigator following 5 days of treatment as compared to baseline

  Up to 8 weeks post-treatment

Study Arms (2)

Active Stimulation

EXPERIMENTAL

Five consecutive days of 20 minutes active stimulation with MyoRegulator® device

Device: MyoRegulator® device

Sham Stimulation

SHAM COMPARATOR

Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device

Device: MyoRegulator® device

Interventions

MyoRegulator® device DEVICE

Trans-spinal DCS paired with peripheral DCS

Also known as: DoubleStim®

Active Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• PathMaker Neurosystems Inc.: lead
• Spaulding Rehabilitation Hospital: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138, United States

Location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02114, United States

Location

Related Publications (2)

• Paget-Blanc A, Chang JL, Saul M, Lin R, Ahmed Z, Volpe BT. Non-invasive treatment of patients with upper extremity spasticity following stroke using paired trans-spinal and peripheral direct current stimulation. Bioelectron Med. 2019 Jul 23;5:11. doi: 10.1186/s42234-019-0028-9. eCollection 2019.

  PMID: 32232101 BACKGROUND

• Estudillo-Guerra MA, Mesia-Toledo I, Rogel N, Yaghoubi N, Ahmed Z, Black-Schaffer R, Morales-Quezada L.Trans-spinal direct current stimulation in spasticity: a literature mini-review. Front. Stroke. 2022 Jul 1;1:921450. doi: 10.3389/fstro.2022.921450.

  BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 8, 2021
• Study Start: March 4, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2023-11

Locations

US (2)