10 Participants Needed

Electrical Stimulation for ALS

(MND Trial)

KC
RG
Overseen ByRaquel Garcia, SLP.D, CCC-SLP, BCS-S
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Southeastern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether electrical stimulation on the face can reduce jaw pain and improve chewing for people with ALS (a disease affecting nerve cells in the brain and spinal cord) and PLS (a similar condition). Participants will undergo a single 30-minute session of electrical stimulation using Transcutaneous Electrical Nerve Stimulation, which involves placing pads on the facial muscles. The trial aims to determine if this treatment can also ease oral hygiene tasks. Individuals diagnosed with ALS or PLS who frequently experience jaw pain are eligible to participate. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance daily life for those affected by ALS and PLS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this electrical stimulation is safe for individuals with ALS and PLS?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe. Most studies find that TENS is easy to manage. The most common side effect is mild headaches, with no known negative effects on thinking or memory. This indicates the treatment is quite safe, especially since it lasts only for a single 30-minute session.

TENS is also used for other conditions to help with pain and muscle problems, further supporting its safety. In this trial, researchers will adjust the electrical current to a comfortable level, reducing the chance of discomfort. Overall, for those considering joining this trial, past research suggests the treatment has a good safety record.12345

Why are researchers excited about this trial?

Transcutaneous Electrical Nerve Stimulation (TENS) is unique because it offers a non-invasive way to potentially reduce facial pain and improve jaw mobility in individuals with ALS and PLS. Unlike standard treatments, which often include medications to manage symptoms, TENS uses electrical impulses to stimulate nerves, aiming to improve muscle function and reduce discomfort. Researchers are excited about this technique because it could provide a safer and potentially quicker alternative to managing facial pain without relying on medication.

What evidence suggests that this electrical stimulation is effective for reducing facial pain and improving jaw mobility in ALS and PLS?

Research has shown that transcutaneous electrical nerve stimulation (TENS) can reduce pain and improve muscle function. Studies have found that TENS significantly lessens movement problems in people with ALS, potentially aiding mobility and reducing pain. Some evidence also suggests it eases muscle tightness and enhances overall comfort. In this trial, all participants will receive TENS to evaluate its potential in making activities like chewing and moving the jaw easier and less painful for those with ALS and Primary Lateral Sclerosis (PLS).12367

Are You a Good Fit for This Trial?

This trial is for individuals with Amyotrophic Lateral Sclerosis (ALS) or Primary Lateral Sclerosis (PLS) who experience facial pain and have difficulty with jaw movement and oral hygiene. Specific eligibility criteria are not provided, but typically include a confirmed diagnosis of ALS or PLS, experiencing the symptoms targeted by the intervention, and being able to attend clinic visits.

Inclusion Criteria

I have been diagnosed with ALS or PLS by my neurologist.
I experience jaw pain with a severity of at least 3 out of 10.

Exclusion Criteria

History of pacemaker
Diagnosis of significant cognitive impairment by the treating physician
I have had a stroke before.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single 30-minute electrical stimulation session with pre- and post-intervention assessments

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through a telephone interview

24 hours
1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Electrical Nerve Stimulation
Trial Overview The study tests if Transcutaneous Electrical Nerve Stimulation (TENS), applied to facial muscles, can lessen facial pain and enhance jaw mobility in ALS/PLS patients. It involves one clinic visit for treatment and assessments plus a follow-up phone interview after 24 hours to evaluate effects on pain relief and oral health tasks.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Transcutaneous electrical stimulation to reduce facial pain and improve jaw ROM in ALS and PLS.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials
103
Recruited
12,000+

Citations

Current perspectives on neuromodulation in ALS patientsThe most common side effect of rTMS has been reported to be mild headaches, with no harmful cognitive effects known to date. Transcranial direct ...
Transcutaneous Electrical Stimulation for Spasticity in ...The goal of this clinical trial is to determine if non-invasive electrical stimulation, using an electric stimulator placed on the skin of the patients back ...
Primary Lateral Sclerosis: An Overview - PMC - PubMed CentralFurthermore, there are data to support the effectiveness of some non-pharmacological therapies such as transcutaneous electrical nerve ...
Efficacy of transcutaneous electrical nerve stimulation in ...After the use of transcutaneous electrical neurostimulation of the median and ulnar nerves, there was a significant regression of motor deficit with a decrease ...
The experience of pain symptoms in patients with ...The purpose of our research is to explore the experience of pain symptoms in patients with amyotrophic lateral sclerosis (ALS), provide reference for better ...
Cortico-spinal tDCS in amyotrophic lateral sclerosisCompared to sham stimulation, cortico-spinal tDCS significantly improved global strength, caregiver burden, and quality of life scores, which correlated with ...
High-Definition Transcranial Direct Current Stimulation (HD ...Evidence suggests that anodal tDCS, unlike cathodal tDCS, can induce beneficial functional effects without accelerating the progression of Amyotrophic Lateral ...
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