An interventional study of adaptive DBS (aDBS) in Parkinson's Disease (PD), sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
Among 33 studies in Parkinson Disease by University of Colorado, Denver — 7 open to participants now, 10 under way, none of them phase 3. Parkinson Disease · University of Colorado, Denver.
Among the 33 studies in Parkinson Disease by University of Colorado, Denver, this one is the 18th largest by planned enrollment of the 23 interventional ones, is one of 2 that started in 2026, is one of 17 with no phase, and was the 33rd registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 18 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →7 of the 33 studies in Parkinson Disease by University of Colorado, Denver are open now, in 1 country. Each count lists the studies.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 45 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →33 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 2 started in 2026.
Median enrollment 49 across the 23 interventional studies, 15 across the 10 observational. Of the 22 that completed or were terminated, 8 (36%) have results posted.
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
3 of the studies in Parkinson Disease by University of Colorado, Denver that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06296810University of Colorado, DenverAdaptive DBS to Offset STN Dysregulation During Exercise in PD | 2026-12 |
| NCT04796506University of Colorado, DenverSlow Wave Sleep as a Biomarker of Rehabilitation-induced Cognitive Improvement in PD | 2027-05-31 |
| NCT06778135University of Colorado, DenverNeocortical Microarchitecture of Executive Function | 2027-10 |
Among the 33 studies in Parkinson Disease by University of Colorado, Denver, from their registry updates:
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.
Parkinson disease (PD) is the second most common age-related neurodegenerative disease worldwide, and is the fastest growing neurologic disorder in prevalence, disability, and deaths. Sleep disturbances have a significant negative impact on quality of life for patients with PD and their caregivers, and may be correlated with faster disease progression. Poor sleep is a known risk factor for cognitive impairment in PD. PD patients spend less time in non-rapid eye movement (NREM) stage 3 (N3) and REM sleep, both of which are critical for memory consolidation and integration with existing knowledge. Reduction in N3 sleep and slow waves (SWs, a hallmark of N3) is associated with poorer cognitive performance and a higher likelihood of cognitive impairment. Targeted and highly efficacious therapies for sleep disorders in PD are lacking and therefore remain a crucial unmet need for the care of people with PD. Further studies are warranted to better understand the pathophysiologic mechanisms of sleep disorders in PD and aid in the development of improved treatments. Basal ganglia-thalamic-cortical circuits, as hubs for cortical-subcortical transmissions, may contribute to or be modulated by aberrant sleep circuits and thus provide critical insight into these complex disorders. Prior work by our group has demonstrated significant band power differences in the subthalamic nucleus (STN) across the sleep-wake cycle, which corroborate cortical patterns of sleep and thus provide support for the basal ganglia as important node for sleep-wake cycling. Patients treated with deep brain stimulation (DBS) represent a unique opportunity to sample relevant basal ganglia electrophysiology. Furthermore, treatment with DBS often leads to an improvement in both subjective and objective sleep measures, but the physiological mechanisms by which this may occur remain unknown. Recently FDA-approved adaptive DBS (aDBS) technology allows for real-time, closed-loop stimulation adjustment based on LFP activity. aDBS therapy provides at least comparable control of motor symptoms during wakefulness compared to cDBS, and is preferred by patients over cDBS for improvement in motor symptoms or reduction of adverse effects of stimulation. aDBS can operate in two modes: single-threshold (ST-aDBS) or dual-threshold (DT-aDBS). DT-aDBS is used more commonly by clinicians, and is preferred over ST-aDBS by patients, and so will be the focus of the present study. The dual threshold algorithm directs the neurostimulator to increase stimulation amplitude when the power of the LFP is above the upper threshold, and to decrease stimulation amplitude when the power of the LFP drops below the lower threshold, but to hold the stimulation amplitude when the power of the LFP remains between the thresholds. We hypothesize that wake-defined aDBS thresholds result in reduced adaptive engagement during sleep due to lower beta power, and that recalibration will restore dynamic threshold crossings.
Study Research Question How can adaptive deep brain stimulation (aDBS) therapy be optimized to address sleep dysfunction in people with advanced Parkinson disease already treated with DBS? Primary objective - Aim 1 To characterize the effect of aDBS on neurophysiological biomarkers in sleep and sleep physiology.
Primary outcome measure - Aim 1 Number of LFP threshold crossings during sleep (sleep stages N2 and N3) per hour.
Secondary outcome measure - Aim 1 Percentage of sleep time (N2, N3) that LFP power is above the upper threshold, below the lower threshold, and between thresholds. These metrics will be analyzed using linear mixed-effects models with a fixed effect for sleep stage and participant/hemisphere as a random intercept.
Exploratory outcome measures - Aim 1
Primary objective - Aim 2 To personalize and test sleep-tailored aDBS thresholds to restore adaptive engagement during sleep Primary outcome measure - Aim 2 Change in number of threshold crossings per hour of N2 and N3 sleep, comparing baseline (Aim 1) vs. sleep-tailored aDBS (Aim 2).
Secondary outcome measures - Aim 2 Change percentage of sleep time (N2, N3) that LFP power is between thresholds, below the lower threshold, and above the upper threshold, comparing baseline sleep study vs. sleep-tailored aDBS.
Exploratory outcome measures - Aim 2 Change in sleep architecture outcomes (N3 proportion, N2 proportion, REM proportion, sleep efficiency, total sleep time, arousal index) during lab-based PSG, comparing sleep-tailored aDBS (Aim 2) to the baseline daytime-optimized aDBS (Aim 1).
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.
Population: We will enroll 18 participants with PD treated with DBS from the Movement Disorders Center at the University of Colorado. Participants must have a Medtronic DBS system, including the Percept RC implanted pulse generator with SenSight model DBS leads (which are optimized for sensing and recording of LFP data), and be using aDBS therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adaptive deep brain stimulation (aDBS) therapy
Device: 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'.
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.
Time frame: 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).
Time frame: From baseline to visit 5
Percentage of sleep time (N2, N3) that LFP power is above the upper threshold, below the lower threshold, and between thresholds
Percentage of sleep time (N2, N3) that LFP power is above the upper threshold, below the lower threshold, and between thresholds. These metrics will be analyzed using linear mixed-effects models with a fixed effect for sleep stage and participant/hemisphere as a random intercept.
Time frame: Baseline
Percentage of sleep time (N2, N3) that LFP power is between thresholds, below the lower threshold, and above the upper threshold
Change percentage of sleep time (N2, N3) that LFP power is between thresholds, below the lower threshold, and above the upper threshold, comparing baseline sleep study vs. sleep-tailored aDBS.
Time frame: From baseline to visit 5
Average beta LFP power per 30-second epoch
Average beta LFP power per 30-second epoch
Time frame: Baseline
Beta LFP power in the 30 seconds preceding each scored arousal compared to matched control epochs of stable N2/N3 sleep
Beta LFP power in the 30 seconds preceding each scored arousal compared to matched control epochs of stable N2/N3 sleep
Time frame: Baseline
Plan to share: Undecided
Start is estimated for Dec 2026; primary completion for Jul 2028, 19 months later.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 19 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: start Aug 2026 → Dec 2026, primary completion Sep 2028 → Jul 2028 and completion Sep 2028 → Jul 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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