Shoulder Pacemaker for Dyskinesia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Rotator cuff tear, arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a shoulder pacemaker, a device that regulates shoulder movement, can assist individuals with scapular dyskinesis or posterior shoulder instability. These conditions disrupt shoulder movement, often leading to pain or discomfort. Researchers will use the pacemaker during physical therapy sessions to determine its effect on pain levels. Individuals with shoulder movement issues, but without rotator cuff tears or arthritis, may be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to explore innovative treatment options for shoulder movement issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use wearable electrical medical devices, they will need to be turned off, or you may be excluded from the study.

What prior data suggests that the shoulder pacemaker is safe for treating scapular dyskinesis or posterior shoulder instability?

Research has shown that the shoulder pacemaker treatment is generally well-tolerated. In one study, patients using the shoulder pacemaker improved quickly, and their positive results lasted for up to two years. This suggests the treatment is safe for long-term use. However, the shoulder pacemaker, which uses nerve stimulation, should not be used on patients at high risk for surgery or those with multiple illnesses or infections. Overall, the treatment appears safe for most people, but discussing personal health concerns with a doctor is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Shoulder Pacemaker is unique because it offers a novel approach for managing dyskinesia by directly stimulating muscles in the shoulder. Unlike standard treatments for dyskinesia, which often rely on medications like Levodopa or deep brain stimulation to manage symptoms, this pacemaker targets the shoulder muscles to help control unwanted movements. Researchers are excited about this treatment because it provides a targeted, non-invasive option that could offer a more direct and potentially side-effect-free way to improve motor function during physical therapy sessions.

What evidence suggests that the shoulder pacemaker is effective for scapular dyskinesis?

Research has shown that the shoulder pacemaker, which participants in this trial will receive, effectively treats shoulder movement issues and instability. One study found quick improvement and lasting benefits over two years. The device corrects abnormal muscle movements, helping to reduce pain during arm movement. Patients reported less pain after using the device during physical therapy. This suggests the shoulder pacemaker could be a promising option for managing these shoulder problems. ^{1 3 4 6 7}

Who Is on the Research Team?

Robert Z Tashjian, MD

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for individuals with Scapular Dyskinesis or Posterior Shoulder Instability who haven't found relief through other treatments. It's not suitable for those with rotator cuff tears, shoulder arthritis, or anyone using implantable or wearable electrical medical devices like pacemakers and glucose sensors.

Inclusion Criteria

I have abnormal movement in my shoulder blade.

My shoulder is unstable and tends to dislocate backwards.

Exclusion Criteria

You have a medical device implanted in your body that uses electricity.

I have shoulder arthritis.

I have a torn rotator cuff.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated using the Shoulder Pacemaker for 15-30 minutes during physical therapy sessions at 3-month, 6-month, and 12-month intervals

12 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shoulder Pacemaker

Trial Overview

The study is testing a 'shoulder pacemaker' to see if it can improve pain and movement in patients with shoulder dyskinesia. Participants will undergo rehabilitation using this device, and their pain levels will be monitored to assess effectiveness.

How Is the Trial Designed?

Group I: Shoulder Pacemaker Treatment Experimental Treatment 1 Intervention

The patients will be treated using the pacemaker for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) significantly improved dyskinesia in pediatric patients with dyskinetic cerebral palsy (DCP) over a follow-up period of 36 months, as measured by the Dyskinesia Impairment Scale.

Despite the improvement in dyskinesia, other motor and non-motor outcomes did not show significant changes, and there were 12 serious adverse events possibly related to the treatment, highlighting the need for further research with larger patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up of Pediatric Patients with Dyskinetic Cerebral Palsy and Deep Brain Stimulation. Koy, A., Kühn, AA., Schiller, P., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7364790/

Shoulder-Pacemaker Treatment Concept for Posterior ...

The shoulder-pacemaker therapy concept is an effective treatment with rapid improvement and sustained outcome over the course of 2 years.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05116722

Shoulder Pacemaker for Scapular Dyskinesia

The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder ...

3.

withpower.com

withpower.com/trial/phase-dyskinesias-8-2021-f20ef

Shoulder Pacemaker for Dyskinesia · Info for Participants

The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder ...

4.

clinicaltrial.be

clinicaltrial.be/en/details/176129?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Shoulder Pacemaker for Scapular Dyskinesia - Clinical Tri...

Shoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy. Primary outcomes. 1. Visual ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5578354/

Use of shoulder pacemaker for treatment of functional ...

Using the shoulder pacemaker, the aberrant muscle activation pattern during elevation of the arm was successfully corrected. The patient was ...

6.

neuromodulation.abbott

neuromodulation.abbott/us/en/important-safety-information.html

Important Safety Information

Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10079016/

Functional impact of cardiac implanted devices on ...

This study aimed to examine the effects of CIED implantation on shoulder functions and scapular dyskinesis.