Back to search results

Deep Brain Stimulation for Apathy in Parkinson's Disease

This study is looking at how Deep Brain Stimulation (DBS) might help people with Parkinson's Disease (PD) who experience severe apathy. Apathy is a common symptom in PD, causing reduced interest, motivation, and social engagement, which can significantly affect quality of life. The study will use a specific type of DBS device called Medtronic Percept PC with SenSight Directional Leads. Researchers will measure changes in apathy symptoms between 9 and 15 months after the treatment to see if it's successful. You might be able to join if you are 40 to 75 years old, have a diagnosis of Parkinson's Disease, and severe apathy. The current status of this study is unclear, and it plans to enroll 5 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 5 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Changes in apathy symptoms will be measured between 9 and 15 months after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06991335

VC/VS for Apathy in PD

Not Yet Recruiting
NAAges 40–75InterventionalTreatment
Nora Vanegas
~5 participants
Updated 2025-05-31 on ClinicalTrials.gov
What's tested:Deep Brain 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
Changes in Apathy Symptoms
Measured over 9 to 15 months

Conditions

Parkinson Disease
Deep Brain Stimulation
Apathy

Explore related trials

ApathyParkinson Disease

NCT06991335

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baylor College of Medicine

    Houston, Texasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nora Vanegas-Arroyave, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Nora Vanegas-Arroyave, MD
[email protected]
713-798-5060
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Diagnosis of Parkinson's Disorder as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease (MDS-PD).
Presence of severe apathy as determined by apathy criteria established by the International Society for Central Nervous System Clinical Trials and Methodology Apathy Working Group (ISCTM-AWG).
Apathy severity of -9 to +36, on the Lille Apathy Rating Scale (LARS) for at least 2 years.
Documentation by primary neurologist of refractoriness to treatment for apathy with at least two dopamine-based treatments (e.g., levodopa, dopamine agonist) of sufficient dose and duration.
Pre-DBS neuropsychological testing indicating normal cognition. Participants with mild cognitive impairment who have been evaluated by a cognitive neurologist for consideration of treatment (i.e., cholinesterase inhibitor) if indicated, may be included in the study once treatment has been stabilized for at least 2 months.
Ability and willingness to give informed consent.
Presence of a caregiver/informant who can complete study surveys/interviews related to the study participant.
Stability of antidepressant medication dosing (i.e., SSRIs, Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), etc.) for a minimum of four weeks prior to surgery.

Exclusion

Major neurocognitive disorder (i.e., dementia) as determined by pre-DBS neuropsychological testing.
Explanation of apathy symptoms by comorbid depression as determined by a psychiatric interview including the Montgomery and Asberg depression rating scale (MADRS). Individuals with a MADRS score ≥15 will be excluded.
History of suicide attempt in the past 36 months or current active suicidal ideation (Yes to #2-5 on the Columbia Suicide Severity Rating Scale - C-SSRS).
Current PD-related psychosis (e.g., visual hallucinations).
Any psychiatric, neurological and/or medical condition that makes the subject, in the opinion of the investigators, a poor candidate.
Alcohol/substance use disorder, moderate or severe, within the previous 12 months.
Female who is pregnant or breastfeeding or has plans to become pregnant in the next 24 months.
Any contraindication for MRI.
Presence of any of the following disorders: a) central nervous system infection, b) toxic-metabolic encephalopathy, defined as a syndrome of delirium associated with an identifiable toxin such as a chemical or metabolic disorder, c) multiple sclerosis, d) developmental delay.
Need for diathermy.

What this trial measures

  • Changes in Apathy Symptoms9 to 15 months

    Response will be defined as a reduction of ≥3 points on the Apathy Evaluation Scale (AES) and Clinical Global Impression Scale - Improvement (CGI-I) of 1 or 2 (indicating 1=very much improved or 2=much improved). Higher AES scores are associated with higher apathy levels. Lower CGI-I scores indicate greater improvement in the participant's condition.