Parkinson DiseaseNCT06008717
Double-Blind Clinical Trial of Subthalamic Nucleus Deep Brain Stimulation in Early-Stage Parkinson's Disease
A study testing active subthalamic nucleus deep brain stimulation plus optimal drug therapy and inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy in people with Parkinson Disease, run by Mallory Hacker.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- active subthalamic nucleus deep brain stimulation plus optimal drug therapy and inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2028to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- No contraindications to surgery (i.e., subject does not have uncontrollable medical or psychiatric illness; Exclusion Criteria).
- Age between 50 and 75 years old.
- Dopaminergic therapy for greater than one year and less than four years.
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- 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.
- MRI within normal range (Exclusion Criteria).
- 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.
Who cannot join
- 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
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- 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)
- The expert evaluating physician, based on the full diagnostic assessment, believes that an alternative syndrome is more likely than PD.
- Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
- Dementia as evidenced by a Dementia Rating Score of less than 123.
- Diagnosis of probable behavioral variant frontotemporal dementia or primary progressive aphasia.
- Currently active diagnosis of a major psychiatric disorder.
- Previous brain operation or injury.
- Active participation in another clinical trial for the treatment of PD.
- Subjects with cardiac pacemakers or medical conditions that require repeat MRI scans.
- Evidence of existing dyskinesia
- Any current substance use disorder.
- Any history of recurrent or unprovoked seizures.
- Any prior movement disorder treatments that involved intracranial surgery or device implantation.
- Any other active implanted intracranial device (e.g., cochlear implant) or implanted device to treat movement disorders (e.g., duodopa pump) whether turned on or off.
- A condition requiring or likely to require the use of magnetic resonance imaging (MRI) or diathermy.
- History of suicide attempt.
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
- Inability or unwillingness of subject to give written informed consent.
- Parkinsonian features restricted to the lower limbs for more than three years.
- Treatment with a dopamine receptor blocker or a dopamine-depleting agent in a dose and time course consistent with drug-induced parkinsonism.
- Normal functional neuroimaging of the presynaptic dopaminergic system, as measured by DaTSCAN.
- Rapid progression of gait impairment requiring regular use of a wheelchair.
- Early bulbar dysfunction, defined as one of severe dysphonia, dysarthria (speech unintelligible most of the time), or dysphagia (requiring soft food, nasogastric (NG) tube, or gastrostomy feeding).
- Inspiratory respiratory dysfunction defined as either diurnal or nocturnal inspiratory stridor or frequent inspiratory sighs.
- Recurrent (>1/year) falls because of impaired balance within 3 years of onset.
- Otherwise unexplained pyramidal tract signs, defined as pyramidal weakness or clear pathologic hyperreflexia (excluding mild reflex asymmetry in the more affected limb and isolated extensor plantar response).
- Bilateral symmetric parkinsonism throughout the disease course. The patient or caregiver reports bilateral symptom onset with no side predominance, and no side predominance is observed on objective examination.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized Feasibility Clinical Trial Evaluating Bilateral Stimulation of the Dorsolateral Region of the Subthalamic Nucleus Receiving Hyperdirect (M1/SMA) Input in Subjects With Early-Stage Parkinson's Disease
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
- Being tested
- active subthalamic nucleus deep brain stimulation plus optimal drug therapy, inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active subthalamic nucleus deep brain stimulation plus optimal drug therapyDevice
active subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy
inactive subthalamic nucleus deep brain stimulation plus optimal drug therapyDevice
optimal drug therapy alone with DBS device turned off
| Study group | Role | What they receive |
|---|---|---|
| active subthalamic nucleus deep brain stimulation plus optimal drug therapy | Experimental | active subthalamic nucleus deep brain stimulation; plus optimal drug therapy Receives: 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 Receives: Device: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency and severity of adverse events
frequency and severity of adverse events
Measured: 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
Measured: 24 months
Secondary outcomes (1)
Stopped or Reversed Motor Progression
compare changes in motor progression for active DBS+ODT vs inactive DBS+ODT
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jan 2028 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mallory Hacker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mallory Hacker, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008717
- Sponsor's protocol ID
- G220314
- Status last verified
- Feb 2026
- First submitted
- 23 Dec 2022
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Feasibility Clinical Trial Evaluating Bilateral Stimulation of the Dorsolateral Region of the Subthalamic Nucleus Receiving Hyperdirect (M1/SMA) Input in Subjects With Early-Stage Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06008717
- Acronym / sponsor ID
- G220314
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mallory HackerUniversity, hospital or other
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active subthalamic nucleus deep brain stimulation plus optimal drug therapy | Experimental | Device: active subthalamic nucleus deep brain stimulation plus optimal drug therapyactive subthalamic nucleus deep brain stimulation; plus optimal drug therapy |
| inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy | Active comparator | Device: inactive subthalamic nucleus deep brain stimulation plus optimal drug therapyinactive subthalamic nucleus deep brain stimulation plus optimal drug therapy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- No contraindications to surgery (i.e., subject does not have uncontrollable medical or psychiatric illness; Exclusion Criteria).
- Age between 50 and 75 years old.
Key exclusion criteria (35 listed)
- Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
- Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
- Dementia as evidenced by a Dementia Rating Score of less than 123.
- Diagnosis of probable behavioral variant frontotemporal dementia or primary progressive aphasia.
- Currently active diagnosis of a major psychiatric disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active subthalamic nucleus deep brain stimulation plus optimal drug therapyactive subthalamic nucleus deep brain stimulation (DBS) plus optimal drug therapy | Device | active subthalamic nucleus deep brain stimulation plus optimal drug therapy |
| inactive subthalamic nucleus deep brain stimulation plus optimal drug therapyoptimal drug therapy alone with DBS device turned off | Device | inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy |
Primary outcome
frequency and severity of adverse events
Time frame: 24 months
frequency and severity of adverse events
frequency and severity of adverse cognitive outcome
Time frame: 24 months
decline from baseline at ≥ 1.5 SD (modest) and ≥ 2.0 (substantial) in tests comprising a comprehensive neuropsychological battery
1 secondary outcome
Stopped or Reversed Motor Progression
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing active subthalamic nucleus deep brain stimulation plus optimal drug therapy and inactive subthalamic nucleus deep brain stimulation plus optimal drug therapy in people with Parkinson Disease, run by Mallory Hacker.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mallory Hacker, PhD, MSCI (1-615-875-7437, mallory.hacker@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency and severity of adverse events (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.