NCT05307055

Brief Summary

This study aims to determine whether direct brain stimulation of specific regions and ranges improves cognition in people with Parkinsons Disease (PD) who already have a deep brain stimulator implanted. Research activities consist of 32 subjects undergoing stimulation changes to their device and being administered neurocognitive tests to evaluate the changes. An fMRI scan will also be done at baseline and at weeks 15 and 27. All subjects will undergo the stimulation changes in a randomized double blind crossover study. Evaluation of stimulation changes will be assessed through analysis of neurocognitive data.

Trial Health

77
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
40mo left

Started Jan 2022

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress57%
Jan 2022Aug 2029

Study Start

First participant enrolled

January 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

7.6 years

First QC Date

March 14, 2022

Last Update Submit

June 5, 2025

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (3)

  • Evaluation of motor symptoms

    Effects of theta burst stimulation on changes in baseline motor symptoms will be assessed using the MDS-Unified Parkinson's Disease Rating Scale - Sections III\&IV (MDS-UPDRS III\&IV)

    Baseline, Week 1, Week 2, Week 3, Week 15, Week 27

  • Evaluation of executive functioning

    Effects of theta burst stimulation on changes in baseline cognitive symptoms will be assessed using Delis-Kaplan Executive Function System (D-KEFS).

    Baseline, Week 1, Week 2, Week 3, Week 15, Week 27

  • Neuroimaging

    Effects of theta burst stimulation on changes in baseline resting state functional connectivity will be assessed using functional magnetic resonance imaging.

    Baseline, Week 15, Week 27

Study Arms (2)

Group A

EXPERIMENTAL

double-blinded randomization into theta burst stimulation followed by baseline stimulation

Device: STN DBS - Theta BurstDevice: STN DBS - Gamma

Group B

EXPERIMENTAL

double blinded randomization into baseline stimulation followed by theta burst stimulation

Device: STN DBS - Theta BurstDevice: STN DBS - Gamma

Interventions

STN DBS - Theta BurstDEVICE

200 Hz intraburst stimulation for 0.1 second repeated at intervals of 5hz with an existing device

Group AGroup B
STN DBS - GammaDEVICE

Standard of care gamma stimulation with an existing device

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
  • Age \>18 years old
  • Stable medication regimen for at least 3 months.
  • Patient informed and able to give written consent
  • Able to comply with all testing, follow-ups and study appointments and protocols

You may not qualify if:

  • History of epilepsy or seizure
  • History of dementia
  • History of major substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California Keck School of Medicine

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Darrin Lee, MD PhD

    University of Southern California, Keck School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrin Lee, MD PhD

CONTACT

9495220866darrin.lee@med.usc.edu

Wooseong Choi, BS

CONTACT

8474017335wooseong@usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurological Surgery

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 1, 2022

Study Start

January 11, 2022

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)