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Enrolling by Invitation

NCT Number: NCT05166655

DBS 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Movement task

Behavioral

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

Primary outcomes

  1. Globus pallidus internus local field potentials

    Time frame: baseline

    power in the beta band

  2. Frontal and parietal electrocorticography

    Time frame: baseline

    power in the beta band

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Intra-operative Recordings to Characterize Movement Facilitation in Parkinson's Disease

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2021
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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