VC/VS for Apathy in PD

Launched by NORA VANEGAS · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help people with Parkinson's Disease (PD) who struggle with apathy, which is a lack of interest, motivation, or emotional engagement. Apathy affects about 40% of people with PD and can significantly lower quality of life. The study will test whether stimulating a specific brain area known as the ventral capsule/ventral striatum (VC/VS) can improve motivation and engagement in daily activities. This area is already approved for treating other conditions and has shown promise in improving motivation in past cases.

To participate in this trial, individuals must have a confirmed diagnosis of Parkinson's Disease and experience severe apathy for at least two years that hasn't improved with standard treatments. They also need to have normal cognitive function and be willing to give consent to join the study. Participants can expect to undergo brain stimulation treatment and will be closely monitored to assess its safety and effectiveness. This trial aims to address a significant unmet need for effective treatment options for apathy in people with Parkinson's Disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.