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NCT03815656

Closed Loop DBS Implanted RC+S Study

Enrolling by Invitation
NAAges 18–75InterventionalTreatment
Dennis Turner, M.D.
~46 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:STN aloneGPi aloneSTN + GPiClosed-loop stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.
Measured over baseline and 12 months after IPG implant
+3 more outcomes measured

Conditions

Parkinson Disease

Explore related trials

Parkinson Disease

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Dennis A Turner, M.D. · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
able to give informed consent
has no hearing impairment (by self-report)
is a native English speaker

Exclusion

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
is pregnant
is a speech therapist or clinician in a related field
studies linguistics / logopedics

What this trial measures

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

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

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

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