Deep Brain Stimulation for Insomnia

(GPS-I Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Hypnotics

Disqualifiers: Dementia, Neurological disease, Sleep apnea, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific type of brain stimulation can improve sleep in people with Parkinson's disease who suffer from severe insomnia. Researchers will use deep brain stimulation, which sends electrical impulses to certain brain areas, targeting a region linked to sleep through Globus Pallidus Stimulation. Individuals who have lived with Parkinson's for 7 to 20 years and experience severe insomnia may qualify. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance sleep quality for Parkinson's patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently using hypnotics (sleep-inducing drugs).

What prior data suggests that this deep brain stimulation technique is safe for treating insomnia?

Research has shown that deep brain stimulation (DBS) targeting the globus pallidus externus (GPe) is generally safe for patients. Early results suggest that GPe DBS might improve sleep quality for people with Parkinson's disease. Most patients tolerate the treatment well. However, some studies report that while many patients experience significant sleep improvements, others notice only small changes or none at all.

It's important to remember that, like any medical treatment, side effects might occur. These can include changes in health or unusual lab results during the study. Overall, the evidence suggests that GPe DBS is a safe option to consider for sleep issues related to Parkinson’s. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Globus Pallidus Stimulation is unique because it offers a new approach to treating insomnia by targeting the brain directly. Unlike standard treatments for insomnia, which often include medications like benzodiazepines or cognitive behavioral therapy, this method uses deep brain stimulation to potentially regulate sleep patterns more precisely. Researchers are excited about this treatment because it could offer relief to individuals with Parkinson's disease who suffer from severe insomnia, providing a novel way to address their specific sleep disturbances that traditional therapies might not effectively manage.

What evidence suggests that globus pallidus stimulation might be an effective treatment for insomnia?

Research has shown that stimulating a part of the brain called the globus pallidus might improve sleep in people with Parkinson's disease who suffer from severe insomnia. One study found that 16 patients experienced significant sleep improvements, while others noticed smaller changes. This trial will investigate the effects of globus pallidus stimulation on participants' sleep patterns. Some evidence suggests this treatment can reduce insomnia symptoms. However, results vary, and not everyone experiences the same level of improvement. Overall, early findings offer hope for those with sleep problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Pablo Castillo, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people aged 40-80 with Parkinson's Disease who've had symptoms for 7-20 years and suffer from severe insomnia. They shouldn't have dementia, previous brain surgeries like pallidotomy or thalamotomy, be using sleeping pills, or have other major neurological issues. Also, they must be able to visit Jacksonville for follow-ups.

Inclusion Criteria

I have severe trouble sleeping.

I am between 40 and 80 years old.

I have had Parkinson's symptoms for 7 to 20 years.

Exclusion Criteria

You have severe memory and thinking problems.

I have had a previous brain surgery for movement disorders.

Inability to travel to Jacksonville for post-operative study visits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive unilateral DBS electrode stimulation to the globus pallidus externa (GPe) region

6 months

Follow-up

Participants are monitored for changes in sleep quality and insomnia severity

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Globus Pallidus Stimulation

Trial Overview The study is testing if activating an extra DBS electrode targeting the globus pallidus externa in the brain can help improve sleep in Parkinson's patients. It involves unilateral deep brain stimulation as a potential treatment for insomnia.

How Is the Trial Designed?

Group I: Adults with Parkinson's disease and severe insomnia Experimental Treatment 1 Intervention

1 arm study

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(19)31034-1/fulltext

Globus Pallidus Externus Deep Brain Stimulation Treats ... We hypothesize that GPe DBS in patients with PD may have a positive impact on improving sleep quality by reducing insomnia symptoms. We present the first ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11535399/

The effect of pallidal stimulation on sleep outcomes and ... We observed high heterogeneity in sleep response to pallidal stimulation: 16 patients showed clinically meaningful improvement, 9 had minor changes, and 7 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04116996

Globus Pallidus Stimulation to Treat Insomnia Study Overview. Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1353802025006285

Investigating the neural correlates of subjective sleep ... STN-DBS was associated with significant improvements in sleep and arousal disturbances. •. A sweet spot in the left STN was associated with significant ...

5. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000210846

Impact on REM Sleep Behavior Disorder (P1-4.005) This study suggests that GPi DBS may have a statistically significant effect on RBD in patients with PD. Most RBDSQ scores decreased between one and three ...

6. thejns.org thejns.org/view/journals/j-neurosurg/130/1/article-p109.xml

Clinical outcomes following awake and asleep deep brain ... In patients undergoing GPi stimulation, the primary outcome of stimulation-induced change in UPDRS-III score was no different for awake patients ...