Is NCT06649955 recruiting in Boston, MA?

Yes, NCT06649955 is currently recruiting participants at its Boston, MA location. This als - amyotrophic lateral sclerosis clinical trial is actively enrolling qualified participants.

How do I join the als - amyotrophic lateral sclerosis clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

ALS - Amyotrophic Lateral Sclerosis Clinical Trial in Boston, MA

About This ALS - Amyotrophic Lateral Sclerosis Study in Boston

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.

Sponsor: PathMaker Neurosystems Inc.

Who Can Participate

Inclusion 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 least 30 days prior to the onset of participation in the study

ALS Functional Rating Score (ALSFRS-R) of greater than or equal to 35

Willing and able to give informed consent

Exclusion Criteria

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 prostheses or metal due to any injury; dental fillings are permitted. Jewelry must be removed during stimulation

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06649955) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

ALS - Amyotrophic Lateral Sclerosis Treatment Options in Boston, MA

If you're searching for als - amyotrophic lateral sclerosis treatment options in Boston, MA, this clinical trial (NCT06649955) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced als - amyotrophic lateral sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all als - amyotrophic lateral sclerosis clinical trials near you to find additional studies recruiting in your area.

ALS - Amyotrophic Lateral Sclerosis Clinical Trial in Boston, MA

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No-Cost Care

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