Parkinson DiseaseNCT05166655
DBS Recordings to Characterize Movement Facilitation in Parkinson's Disease
A study testing Movement task in people with Parkinson Disease, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Movement task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia)
- Undergoing deep brain stimulation surgery for treatment of advanced Parkinson's disease, according to clinical evaluation, including the following criteria:
- advanced idiopathic PD as determined by OFF unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale > 25
- L-dopa responsive symptoms with at least 30% improvement in UPDRS III scores on vs. off medication OR medication refractory disabling tremor
- Persistent disabling motor symptoms or drug side effects (dyskinesias, motor fluctuations, disabling "off" periods) despite optimal medical therapy
- preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
- Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
Who cannot join
- medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week
- significant cognitive or psychiatric disease based on clinical neuropsychological testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Intra-operative Recordings to Characterize Movement Facilitation in Parkinson's Disease
Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use intraoperative recordings during DBS surgery for Parkinson's disease to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during awake surgery performed exclusively for clinical indications. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait.
Read the detailed description
Patients with Parkinson's disease (PD) will perform computer tasks involving reaching and tapping movements during video recording of movements and electrophysiological recording of brain signals during deep brain stimulation surgery. Experimental manipulations involve different computer stimuli that manipulate the presence or absence of sensory and motivational movement cues. The same experimental manipulations are delivered to all individual subjects. 40 PD patients who are undergoing deep brain stimulation (DBS) surgery for treatment of Parkinson's disease, will perform the tasks during awake surgery and recordings will be obtained from 2 implanted DBS electrodes as well as 2 temporary electrode strips placed on the surface of the brain for research purposes. Study procedures are limited to the intraoperative environment with no additional study visits. All patients will also be asked to perform clinical rating scales and questionnaires and undergo a movement disorders neurological exam.
- Conditions
- Parkinson Disease
- Being tested
- Movement task
- Keywords
- deep brain stimulation, neuromodulation, external cueing, movement
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement taskBehavioural
Computer task with experimental conditions manipulating sensory and motivation cues for movement.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease patients | Experimental | Parkinson disease patients undergoing DBS Surgery of the Globus Pallidus Internus (GPi) for clinical indications Receives: Behavioral: Movement task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Globus pallidus internus local field potentials
power in the beta band
Measured: baseline
Frontal and parietal electrocorticography
power in the beta band
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start3 Mar 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn A. Cross, MD, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166655
- Sponsor's protocol ID
- 21-001271
- Other IDs
- 1K23NS119568
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Electrophysiological and behavioral data obtained during task performance will be made available upon request to Dr. Cross (PI) via secured server access. Data sharing agreement will be required for all requests.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Recordings to Characterize Movement Facilitation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05166655
- Acronym / sponsor ID
- 21-001271
- Conditions
- Parkinson Disease
- Keywords
- deep brain stimulation, neuromodulation, external cueing, movement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use intraoperative recordings during DBS surgery for Parkinson's disease to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during awake surgery performed exclusively for clinical indications. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait.
Detailed description
Patients with Parkinson's disease (PD) will perform computer tasks involving reaching and tapping movements during video recording of movements and electrophysiological recording of brain signals during deep brain stimulation surgery. Experimental manipulations involve different computer stimuli that manipulate the presence or absence of sensory and motivational movement cues. The same experimental manipulations are delivered to all individual subjects. 40 PD patients who are undergoing deep brain stimulation (DBS) surgery for treatment of Parkinson's disease, will perform the tasks during awake surgery and recordings will be obtained from 2 implanted DBS electrodes as well as 2 temporary electrode strips placed on the surface of the brain for research purposes. Study procedures are limited to the intraoperative environment with no additional study visits. All patients will also be asked to perform clinical rating scales and questionnaires and undergo a movement disorders neurological exam.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease patients | Experimental | Behavioral: Movement taskParkinson disease patients undergoing DBS Surgery of the Globus Pallidus Internus (GPi) for clinical indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of idiopathic Parkinson's disease based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia)
- Undergoing deep brain stimulation surgery for treatment of advanced Parkinson's disease, according to clinical evaluation, including the following criteria:
- advanced idiopathic PD as determined by OFF unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale > 25
- L-dopa responsive symptoms with at least 30% improvement in UPDRS III scores on vs. off medication OR medication refractory disabling tremor
- Persistent disabling motor symptoms or drug side effects (dyskinesias, motor fluctuations, disabling "off" periods) despite optimal medical therapy
Key exclusion criteria (2 listed)
- medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week
- significant cognitive or psychiatric disease based on clinical neuropsychological testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement taskComputer task with experimental conditions manipulating sensory and motivation cues for movement. | Behavioural | Parkinson disease patients |
Primary outcome
Globus pallidus internus local field potentials
Time frame: baseline
power in the beta band
Frontal and parietal electrocorticography
Time frame: baseline
power in the beta band
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Electrophysiological and behavioral data obtained during task performance will be made available upon request to Dr. Cross (PI) via secured server access. Data sharing agreement will be required for all requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement task in people with Parkinson Disease, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Globus pallidus internus local field potentials (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.