Recruiting

aDBS

Sponsor:

University of Colorado, Denver

Code:

NCT07808346

Conditions

Parkinson's Disease (PD)

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

adaptive DBS (aDBS)

Study Details

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)

Study ID

NCT07808346

Start date

Dec 1, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: aDBS

Adaptive deep brain stimulation (aDBS) therapy

Interventions

adaptive DBS (aDBS)

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'.

Primary outcome measure

  • Number of LFP threshold crossings during sleep (sleep stages N2 and N3) per hour [ Time Frame: Baseline ]
  • Number of threshold crossings per hour of N2 and N3 sleep [ Time Frame: From baseline to visit 5 ]

Central Contacts and Locations

Central contacts

Neurology Recruitment Partner Neurology Recruitment Partner

3037244644Neuroresearch@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 30, 2026

Last verified

Sep, 2026

Keywords

  • Deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.