NCT07110376 Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease
| NCT ID | NCT07110376 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-11-22 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-11-22 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07110376 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07110376 currently recruiting?
Yes, NCT07110376 is actively recruiting participants. Contact the research team at ANISS2@ccf.org for enrollment information.
Where is the NCT07110376 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07110376 clinical trial?
NCT07110376 is sponsored by The Cleveland Clinic. The trial plans to enroll 10 participants.
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