---
title: Improve sleep using brain pulses
nct_id: NCT07110376
phase: NA
status: RECRUITING
sponsor: The Cleveland Clinic
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07110376"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07110376"
last_fetched: "2026-05-10T14:08:28.316Z"
source: "Parkinson's Pathways (curated)"
---
# Improve sleep using brain pulses

**Goal (in five words):** Improve sleep using brain pulses

**Official Title:** Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study

**Trial ID:** [NCT07110376](https://clinicaltrials.gov/study/NCT07110376)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** The Cleveland Clinic
- **Target Enrollment:** 10 participants
- **Start Date:** 2025-11-22
- **Completion Date:** 2026-07-01
- **Conditions:** Parkinson Disease
- **Interventions:** Nighttime Deep Brain Stimulation with Varying Amplitude Settings
- **Intervention Types:** OTHER

## Summary For Families

The DREAMS-PD team wants to know whether changing the amplitude of overnight deep brain stimulation changes brain activity during sleep and may affect overnight symptoms like movement or sleep quality. They will use the Medtronic Percept PC, which delivers electrical pulses to the subthalamic nucleus to calm abnormal Parkinson's-related brain rhythms and also records local brain signals; by varying the stimulation amplitude at night they can see how different settings alter sleep-related neural patterns while keeping daytime therapy and medications stable. Adults over 18 with idiopathic Parkinson's who already have bilateral Percept PC STN implants with settings optimized for at least three months, report some sleep problems, can walk independently, do not have dementia or untreated significant sleep apnea, and keep sleep medications stable are eligible.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Male or female \> 18 years of age
* Diagnosed with idiopathic Parkinson Disease
* Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months
* Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I;
* Demonstrate ability to ambulate independently;
* Be capable of providing informed consent;
* If taking sleep-supporting medications, dosing must be stable for at least 30 days

Exclusion Criteria:

* Presence of neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis
* Active sleep disorders, including narcolepsy, moderate to severe (Apnea-Hypopnea Index\>=15) untreated sleep apnea, uncontrolled restless legs syndrome
* Cognitive impairment meeting the criteria for dementia as per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), based on formal neuropsychological evaluation
* Ongoing alcohol or substance abuse; Working night shifts or irregular work hours

The main concern for vulnerable subjects will be for the possibility of reduced decision-making capacity. For this we intend to exclude individuals who have a diagnosis of dementia.
```

## Locations (1)

- Cleveland Clinic, Cleveland, Ohio, United States _(41.4995, -81.6954)_
  - Project Manager — (CONTACT) — 216-372-2867 — beukemm@ccf.org
  - Saar Anis, MD — (CONTACT) — 216 678-8896 — ANISS2@ccf.org
  - James Liao, MD — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Saar Anis, MD — (CONTACT) — 216 678-8896 — ANISS2@ccf.org

---

*Canonical: https://parkinsonspathways.com/trial/NCT07110376*  
*HTML version: https://parkinsonspathways.com/trial/NCT07110376*  
*Source data: https://clinicaltrials.gov/study/NCT07110376*