Status:
NOT_YET_RECRUITING
VC/VS for Apathy in PD
Lead Sponsor:
Nora Vanegas
Conditions:
Parkinson Disease
Deep Brain Stimulation
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
Apathy is a disabling neuropsychiatric symptom marked by reduced goal-directed behavior, including diminished interest, motivation, emotional expression, and social engagement. Though not formally def...
Detailed Description
Apathy is a significant mental health condition. Apathy was originally defined as a disorder of motivation and is now operationalized as a reduction in goal-directed behavior. It manifests with dimini...
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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06991335
Start Date
September 1 2025
End Date
September 1 2032
Last Update
May 31 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030