---
title: Improve insomnia with pallidal stimulation
nct_id: NCT04116996
phase: NA
status: RECRUITING
sponsor: Mayo Clinic
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT04116996"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04116996"
last_fetched: "2026-05-10T14:02:31.616Z"
source: "Parkinson's Pathways (curated)"
---
# Improve insomnia with pallidal stimulation

**Goal (in five words):** Improve insomnia with pallidal stimulation

**Official Title:** Stimulation of the External Pallidal Segment for Insomnia in Patients With Parkinson's Disease

**Trial ID:** [NCT04116996](https://clinicaltrials.gov/study/NCT04116996)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Mayo Clinic
- **Target Enrollment:** 10 participants
- **Start Date:** 2019-01-01
- **Completion Date:** 2029-01-01
- **Conditions:** Parkinson Disease
- **Interventions:** DEEP BRAIN STIMULATION
- **Intervention Types:** DEVICE

## Summary For Families

Aiming to ease the severe insomnia that many people with Parkinson's struggle with, this trial targets nighttime wakefulness and poor sleep quality that do not respond well to medications. It implants a deep brain stimulation lead in the external segment of the globus pallidus, delivering adjustable electrical pulses to modulate basal ganglia circuits that influence sleep and arousal, and it is used in addition to existing treatments like levodopa rather than replacing them. By changing abnormal firing patterns in that region, stimulation may reduce the brain overactivity that fragments sleep and help restore more stable sleep architecture. The study seeks people aged 40 to 80 with 7 to 20 years of Parkinsonism and severe insomnia on the ISI, and it excludes those with significant dementia, very early or very advanced disease, severe sleep apnea, prior pallidal/thalamic surgeries or other implants, current hypnotic use, or insomnia due to untreated mood disorder or pain.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* 40-80 years of age
* Symptomatic with Parkinsonism for 7-20 years
* Severe insomnia based on ISI score

Exclusion Criteria:

* Clinically significant dementia (MMSE \<23)
* Hoehn \& Yahr \[Hoehn, 1967 #1839\] stage I or V disease
* Other significant neurological or psychiatric disease
* Previous pallidotomy or thalamotomy
* Previous placement of other implantable devices
* Secondary parkinsonism (non-idiopathic parkinsonism)
* Inability to travel to Jacksonville for post-operative study visits
* Severe sleep apnea
* Insomnia due to pain or untreated mood disorder
* Contraindications to 3T MRI
* Circadian rhythm sleep disorders.
* Current use of hypnotics
```

## Locations (1)

- Mayo Clinic in Florida, Jacksonville, Florida, United States _(30.3322, -81.6556)_
  - Pablo R Castillo, MD — (CONTACT) — 904-9532000 — castillo.pablo@mayo.edu

---

*Canonical: https://parkinsonspathways.com/trial/NCT04116996*  
*HTML version: https://parkinsonspathways.com/trial/NCT04116996*  
*Source data: https://clinicaltrials.gov/study/NCT04116996*