Status:
COMPLETED
Early Feasibility Study of the MyoRegulator® for Treatment of ALS
Lead Sponsor:
PathMaker Neurosystems Inc.
Collaborating Sponsors:
Spaulding Rehabilitation Hospital
Sean M. Healey & AMG Center for ALS
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). T...
Detailed Description
Amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease) is a progressive neurodegenerative disease that affects motor neurons in spinal cord and brain. ALS causes motor and cognitive function defici...
Eligibility Criteria
Inclusion
- 18 years of age or older
- A clinical diagnosis of ALS as confirmed by medical history
- Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration
- Willing to refrain from participation in any other clinical trial for the duration of this study
- Willing to forgo pregnancy for the duration of the study
- Willing and able to give informed consent or have informed consent provided for them by their legal guardian
- Cognitive function sufficient to understand the study and follow instructions (per interview with appropriate clinician)
Exclusion
- Study participants who are on permanent assisted ventilation (PAV) defined as \>22h of noninvasive or invasive ventilation a day for \> 7 consecutive days.
- Implanted intrathecal pump
- Prior botulinum toxin injection(s) within 12 weeks of study enrollment
- Prior phenol or alcohol injections within 6 months of study enrollment
- Presence of potential risk factors for trans-spinal direct current stimulation:
- 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
- Any medical condition that would prevent the participant from being able to participate in the clinical outcome measures
- Pregnant females, as determined by a pregnancy test at enrollment (in females of child-bearing potential)
Key Trial Info
Start Date :
June 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06165172
Start Date
June 21 2023
End Date
August 31 2024
Last Update
March 25 2025
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129