NCT03815656

Brief Summary

This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:

  1. 1.to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and
  2. 2.to develop an adaptive DBS system using brain signals measured from these two electrodes.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
7mo left

Started Jul 2019

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 Progress92%
Jul 2019Jan 2027

First Submitted

Initial submission to the registry

January 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 10, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

7.5 years

First QC Date

January 17, 2019

Last Update Submit

February 15, 2026

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (4)

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.

    Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 12 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).

    baseline and 12 months after IPG implant

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 24 months after IPG implant.

    Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 24 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).

    baseline and 24 months after IPG implant

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.

    Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 48 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).

    baseline and 48 months after IPG implant

  • Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 72 months after IPG implant.

    Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 72 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).

    baseline and 72 months after IPG implant

Secondary Outcomes (12)

  • Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 12 months after IPG implant.

    baseline and 12 months after IPG implant

  • Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 24 months after IPG implant.

    baseline and 24 months after IPG implant

  • Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 48 months after IPG implant.

    baseline and 48 months after IPG implant

  • Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 72 months after IPG implant.

    baseline and 72 months after IPG implant

  • Change in percentage of waking hours with good "on" time at 12 months after IPG implant.

    baseline and 12 months after IPG implant

  • +7 more secondary outcomes

Other Outcomes (1)

  • Intelligibility Rating of Recorded Sentences

    1 hour

Study Arms (2)

Implanted RC+S

EXPERIMENTAL

Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.

Device: STN aloneDevice: GPi aloneDevice: STN + GPiDevice: Closed-loop stimulation

speech rater

NO INTERVENTION

blinded raters to score audio recordings of speech

Interventions

STN aloneDEVICE

DBS stimulation of STN alone

Implanted RC+S
GPi aloneDEVICE

DBS stimulation of GPi alone

Implanted RC+S
STN + GPiDEVICE

cooperative DBS stimulation of STN and GPi sites

Implanted RC+S
Closed-loop stimulationDEVICE

adaptive DBS stimulation of STN and/or GPi sites

Implanted RC+S

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • able to give informed consent
  • diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
  • has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
  • has off-on improvement with levodopa of at least 30%
  • is available for follow-up visits for length of study
  • is not safe surgical candidate for DBS
  • has severe neurological injury or disease other than Parkinson's Disease
  • has condition requiring repeated MRI scans
  • has untreated, clinically significant depression
  • has an electrical or electromagnetic implant
  • had a prior thalamotomy or surgical ablation procedure
  • has dementia interfering with ability to comply with study requirements or give informed consent
  • abuses drugs or alcohol
  • has a history of seizures
  • has any metallic implants
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Mitchell KT, Schmidt SL, Cooney JW, Grill WM, Peters J, Rahimpour S, Lee HJ, Jung SH, Mantri S, Scott B, Lad SP, Turner DA. Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain Stimulation Trial in Parkinson Disease Using Summit RC + S. Neurosurgery. 2022 Jul 1;91(1):132-138. doi: 10.1227/neu.0000000000001957. Epub 2022 Apr 7.

    PMID: 35383660DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dennis A Turner, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Neurosurgery

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 24, 2019

Study Start

July 10, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

IPD to be shared: IPD for all participants that support the primary and secondary outcome measures listed in clinicaltrials.gov, after deidentification.

Shared Documents
ICF
Time Frame
Data are available now through the end of funding (estimated January 2027). Additional data are updated on an annual basis.
Access Criteria
Supporting Information (informed consent form) is available on clinicaltrials.gov. IPD are available by request at the Data Archive for the BRAIN Initiative (dabi.loni.usc.edu). Requests for access will be evaluated through the end of grant funding (estimated January 2027).
More information

Locations

US(1)