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

20 Participants Needed

Trial Summary

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.

How is the Shoulder Pacemaker treatment different from other treatments for dyskinesia?

The Shoulder Pacemaker treatment is unique because it likely involves a novel approach to managing shoulder dyskinesia, potentially through electrical stimulation, which is different from traditional methods like botulinum toxin injections or surgical interventions. This approach may offer a new option for patients who do not respond to existing treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder Instability who undergo rehabilitation with a shoulder pacemaker.

Research Team

Robert Z Tashjian, MD

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Levodopa-induced dyskinesia and thalamotomy. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Deep brain stimulation reduces (nocturnal) dyskinetic exacerbations in patients with ADCY5 mutation: a case series. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Denervation of the infraspinatus and release of the posterior deltoid muscles in the management of dyskinetic external shoulder rotation in cerebral palsy. [2018]

4. France pubmed.ncbi.nlm.nih.gov

[Value of bifocal stereotaxic destruction in case of dyskinesia in patients with a motor deficit of cerebral origin]. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up of Pediatric Patients with Dyskinetic Cerebral Palsy and Deep Brain Stimulation. [2023]