Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease

NCT07808346 | Active Not Recruiting FDA Device

• 2 other identifiers: 26-0308K12TR004412-03
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional study of a cohort of patients with PD treated with DBS, and already utilizing adaptive DBS (dual threshold mode). In Aim 1, we will obtain baseline sleep and basal ganglia physiology data to inform aDBS parameter changes. Aim 2 involves 15 nights of in-home monitoring of subjective and objective sleep quality, during which participants will use 3 different sleep-tailored aDBS settings at night only. Participant preference among these 3 settings will determined the 'optimized sleep-tailored aDBS mode'. Participants will undergo repeat polysomnography, while in the optimized sleep-tailored aDBS mode, to compare aDBS behavior and sleep architecture to the baseline (Aim 1) sleep study.

Conditions

Parkinson's Disease (PD)

Keywords

Deep brain stimulation

Outcome Measures

Primary Outcomes (2)

• Number of LFP threshold crossings during sleep (sleep stages N2 and N3) per hour

  Number of LFP threshold crossings during sleep (sleep stages N2 and N3) per hour.

  Baseline

• Number of threshold crossings per hour of N2 and N3 sleep

  Change in number of threshold crossings per hour of N2 and N3 sleep, comparing baseline (Aim 1) vs. sleep-tailored aDBS (Aim 2).

  From baseline to visit 5

Secondary Outcomes (2)

• Percentage of sleep time (N2, N3) that LFP power is above the upper threshold, below the lower threshold, and between thresholds

  Baseline

• Percentage of sleep time (N2, N3) that LFP power is between thresholds, below the lower threshold, and above the upper threshold

  From baseline to visit 5

Other Outcomes (2)

• Average beta LFP power per 30-second epoch

  Baseline

• Beta LFP power in the 30 seconds preceding each scored arousal compared to matched control epochs of stable N2/N3 sleep

  Baseline

Study Arms (1)

aDBS

EXPERIMENTAL

Adaptive deep brain stimulation (aDBS) therapy

Device: adaptive DBS (aDBS)

Interventions

adaptive DBS (aDBS) DEVICE

Participants will use 3 different sleep-tailored aDBS settings at night only. Participant preference among these 3 settings will determined the 'optimized sleep-tailored aDBS mode'.

aDBS

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, in the age range of 45 to 75 years (inclusive)
• Have a smart phone and be willing and able to download the app required for the Waveband and SEMA3
• Are able to use the Waveband app
• Diagnosis of idiopathic PD and treatment with STN or GPi DBS using the Medtronic system, including SenSight (model B33005 or B33015) leads and Percept RC (model B35300) implanted pulse generator
• Hoehn and Yahr stage 2-3 (on medication, on DBS) at the time of enrollment
• Taking unchanged doses of antiparkinsonian medications for at least 4 weeks prior to study enrollment.
• Stable and optimized (for motor symptom control) DBS therapy settings, using adaptive DBS in the dual threshold mode. 'Stable and optimized 'will be defined by the following: 1) no changes made to DBS stimulation parameters within the last 30 days, and 2) improvement of PD motor symptoms, as determined by the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part III, of at least 30% between the stimulation off and on conditions.

You may not qualify if:

• Clinical diagnosis of dementia
• Current or recent (within the past 30 days) use a sedative-hypnotic drug (including medications known to affect SPs or SWs such as benzodiazepines40)
• Participants who fulfill criteria for or carry a diagnosis of a circadian sleep-wake disorder as defined by the International Classification of Sleep Disorders, 3rd Edition41
• Shift workers
• Presence of any other condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Colorado Clinical and Translational Sciences Institute: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

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MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: August 29, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

US (1)