Parkinson's Disease Trial, Not Yet Recruiting NCT06991335 Sponsor: Nora Vanegas Condition: Parkinson's Disease
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Parkinson's Disease Trial, Not Yet Recruiting

NCT06991335
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with Parkinson's disease, as defined by an internationally recognised set of clinical diagnostic criteria.
  • People who have severe apathy (a significant lack of motivation or emotional engagement), as determined by established clinical criteria for apathy.
  • People whose apathy falls within a specific range on a recognised apathy rating scale (called the Lille Apathy Rating Scale, or LARS), and who have had this level of apathy for at least 2 years.
  • People whose primary neurologist has documented that their apathy has not responded to at least two different dopamine-based medications (such as levodopa or dopamine agonists) at appropriate doses and for an appropriate duration.
  • People whose pre-surgical cognitive testing shows normal cognition; people with mild cognitive impairment may also be considered if a cognitive specialist has already assessed them and, where relevant, their treatment for cognitive impairment has been stable for at least 2 months.
  • People who are able and willing to give informed consent to participate.
  • People who have a caregiver or someone close to them who is able to complete study surveys and interviews about the participant.
  • People whose antidepressant medication dose (such as SSRIs or SNRIs) has been stable for at least four weeks before surgery.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People with major cognitive decline or dementia, as identified through pre-surgical cognitive testing.
  • People whose apathy appears to be explained by depression, based on a psychiatric interview; people with a score of 15 or higher on a recognised depression rating scale (MADRS) will not be eligible.
  • People who have attempted suicide in the past 36 months, or who are currently experiencing active suicidal thoughts at a level that meets a specific threshold on a recognised safety scale (C-SSRS).
  • People who are currently experiencing Parkinson's-related psychosis, such as visual hallucinations.
  • People who have any psychiatric, neurological, or medical condition that the study investigators consider would make participation unsuitable.
  • People who have had a moderate or severe alcohol or substance use disorder within the past 12 months.
  • People who are pregnant, breastfeeding, or who plan to become pregnant within the next 24 months.
  • People for whom an MRI scan is medically unsafe or not recommended for any reason.
  • People who have any of the following conditions: an infection of the central nervous system; toxic-metabolic encephalopathy (a state of confusion linked to a chemical or metabolic problem in the body); multiple sclerosis; or a developmental delay.
  • People who require a medical treatment called diathermy (a procedure that uses heat generated by high-frequency electrical currents).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Principal Investigator: Nora Vanegas-Arroyave, MD, Baylor College of Medicine

Phone: 713-798-5060

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Nora Vanegas
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 September 2032

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Changes in Apathy Symptoms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov