NCT05166655

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
4mo left

Started Mar 2022

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2022Sep 2026

First Submitted

Initial submission to the registry

December 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

4.5 years

First QC Date

December 16, 2021

Last Update Submit

November 22, 2025

Conditions

Parkinson Disease

Keywords

deep brain stimulationneuromodulationexternal cueingmovement

Outcome Measures

Primary Outcomes (2)

  • Globus pallidus internus local field potentials

    power in the beta band

    baseline

  • Frontal and parietal electrocorticography

    power in the beta band

    baseline

Study Arms (1)

Parkinson disease patients

EXPERIMENTAL

Parkinson disease patients undergoing DBS Surgery of the Globus Pallidus Internus (GPi) for clinical indications

Behavioral: Movement task

Interventions

Movement taskBEHAVIORAL

Computer task with experimental conditions manipulating sensory and motivation cues for movement.

Parkinson disease patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week
  • significant cognitive or psychiatric disease based on clinical neuropsychological testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Residence

Study Record Dates

First Submitted

December 16, 2021

First Posted

December 22, 2021

Study Start

March 3, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)