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New treatment option for ALS - Amyotrophic Lateral Sclerosis
Official title Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
ClinicalTrials.gov ID: NCT06649955
What this study is testing
- What it's testing
- Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM will gather additional preliminary evidence of clinical safety and potential effectiveness in this patient population with a longer follow-up period and additional secondary endpoints in a single-arm study prior to commencing a larger sham-controlled pivotal trial.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 18-80 years of age inclusive
- Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS as defined by revised El Escorial...
- Less than or equal to 3 years since ALS symptom onset
- Slow Vital Capacity ≥ 50% of predicted capacity at the time of Screening as determined using a portable spirometer
- For TTNCS: Median CMAP ≥ 1.5 mV
You likely can't join if
- Study participants who are on permanent assisted ventilation (PAV) defined as \>22h of noninvasive or invasive ventilation a day for \> 7 consecutive...
- Study participants who have been diagnosed with ALS having only clinical bulbar involvement
- Implanted intrathecal pump
- Prior botulinum toxin injection(s) at any site within 12 weeks of study enrollment
- Prior phenol or alcohol injections for spasticity within 6 months of study enrollment
- Presence of potential tsDCS and/or TMS risk factors:
See the full eligibility criteria
- 18-80 years of age inclusive
- Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS as defined by revised El Escorial criteria
- Less than or equal to 3 years since ALS symptom onset
- Slow Vital Capacity ≥ 50% of predicted capacity at the time of Screening as determined using a portable spirometer
- For TTNCS: Median CMAP ≥ 1.5 mV
- 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 therapeutic clinical trial or investigational product for ALS for the duration of this study
- Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and 3 months after study completion.
- Stable dose of rilutek (Riluzole), edaravone (Radicava), or tofersen (Qualsody) and oral medications for muscle spasms/cramps (e.g. mexiletine, quinine, quinidine, magnesium, gabapentin, oxcarbazepine, baclofen) for at...
- ALS Functional Rating Score (ALSFRS-R) of greater than or equal to 35
- Willing and able to give informed consent
- Study participants who are on permanent assisted ventilation (PAV) defined as \>22h of noninvasive or invasive ventilation a day for \> 7 consecutive days.
- Study participants who have been diagnosed with ALS having only clinical bulbar involvement
- Implanted intrathecal pump
- Prior botulinum toxin injection(s) at any site within 12 weeks of study enrollment
- Prior phenol or alcohol injections for spasticity within 6 months of study enrollment
- Presence of potential tsDCS and/or TMS 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.)
- 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
- Ferromagnetic metal in the head, neck or any site of stimulation including, but not limited to, aneurysm clips, implanted medication pumps, implanted brain stimulators, pacemakers, cochlear implants, implanted metal...
- Seizures or unexplained spells of loss of consciousness during the previous 12 months
- Any cardiac abnormality that may be exacerbated by transthoracic electrical stimulation
- History of cord lesions or previous spinal surgery that may interfere with procedure as determined by the study MD
- History of intracranial brain lesions, cortical stroke or previous neurosurgery that may interfere with TMS (e.g., in regions to be stimulated for TMS evaluations) as reviewed and approved by the study MD
- 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 V1 (in females of child-bearing potential)
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.