Double-Blind Clinical Trial of Subthalamic Nucleus Deep Brain Stimulation in Early-Stage Parkinson's Disease

NCT06008717 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: G220314
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this trial is to evaluate the preliminary safety and efficacy of programming to maximize stimulation of the dorsolateral region of the subthalamic nucleus (STN) receiving primary motor (M1) and supplementary motor area (SMA), but not pre-SMA, input deep brain stimulation (DBS) in patients with early-stage Parkinson's disease (PD).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• frequency and severity of adverse events

  frequency and severity of adverse events

  24 months

• frequency and severity of adverse cognitive outcome

  decline from baseline at ≥ 1.5 SD (modest) and ≥ 2.0 (substantial) in tests comprising a comprehensive neuropsychological battery

  24 months

Secondary Outcomes (1)

• Stopped or Reversed Motor Progression

  24 months

Study Arms (2)

active subthalamic nucleus deep brain stimulation plus optimal drug therapy

EXPERIMENTAL

active subthalamic nucleus deep brain stimulation; plus optimal drug therapy

Device: active subthalamic nucleus deep brain stimulation plus optimal drug therapy

inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy

ACTIVE COMPARATOR

inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy

Device: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy

Interventions

inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy DEVICE

optimal drug therapy alone with DBS device turned off

inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy

active subthalamic nucleus deep brain stimulation plus optimal drug therapy DEVICE

active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy

active subthalamic nucleus deep brain stimulation plus optimal drug therapy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of idiopathic Parkinson's disease (PD). The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia.
• Clear and dramatic beneficial response to dopaminergic therapy, defined as ≥30% in UPDRS III with administration of the patient's medication during the screening neurological examination.
• Hoehn and Yahr (H\&Y) stage II when OFF medication.

You may not qualify if:

• Age between 50 and 75 years old.
• Dopaminergic therapy for greater than one year and less than four years.
• Available for follow-up for the entire duration of the study.
• Informed Consent (Appendix C): The subject is willing and able to provide written informed consent.
• Subjects receiving antidepressant medication used specifically for the treatment of depression must be on stable doses for at least eight weeks prior to enrolling in the study.
• Subjects must agree to maintain a stable regimen, if deemed medically appropriate by the treating physician, of any psychotropic medications throughout the blinded treatment phase.
• Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
• Features unusual early in the clinical course (e.g., prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset)
• Dementia preceding motor symptoms
• Neurologic signs of upper motor neuron or cerebellar involvement
• Significant orthostatic hypotension unrelated to medications
• Unequivocal cortical sensory loss (i.e., graphesthesia, sterognosis with intact primary sensory modalities), clear limb ideomotor apraxia, or progressive aphasia
• Vertical supranuclear gaze palsy, or selective slowing of vertical saccades
• Unequivocal cerebellar abnormalities on examination, such as cerebellar gait, limb ataxia, or cerebellar oculomotor abnormalities (e.g., sustained gaze-evoked nystagmus, macro square wave jerks, hypermetric saccades)
• Documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (e.g., MRI scan with evidence of significant brain atrophy, lacunar infarcts, or iron deposits in the putamen; history of stroke, exposure to toxins, or encephalitis; or neuroleptic use within the past 6 months)

Sponsors & Collaborators

• Mallory Hacker: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mallory Hacker, PhD, MSCI

CONTACT

1-615-875-7437; mallory.hacker@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: motor scores will be blindly rated by an independent movement disorders neurologist who will be unaware of treatment assignment, ON vs OFF treatment status, or visit sequence
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: August 24, 2023
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: February 20, 2026

Record last verified: 2026-02