Printed from Voxsanity (voxsanity.com.au) — NCT06008717 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Parkinsons Disease
Parkinson's Disease Trial, Not Yet Recruiting
NCT06008717
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
- A doctor has diagnosed the person with idiopathic (no known cause) Parkinson's disease, based on having at least two of the three main movement symptoms: slowness of movement, shaking at rest, or muscle stiffness — and at least one of those must be shaking at rest or slowness of movement.
- The person's Parkinson's symptoms improve by at least 30% on a standard movement test when taking their Parkinson's medication.
- The person is at a moderate stage of Parkinson's disease (Hoehn and Yahr Stage II) when they are not taking their medication.
- The person does not have any medical or psychiatric conditions that would make surgery unsafe.
- The person is between 50 and 75 years old.
- The person has been taking Parkinson's medication for more than one year but less than four years.
- The person is able to attend all follow-up visits for the full length of the study.
- The person is willing and able to sign a written consent form agreeing to take part.
- A brain MRI scan has come back within a normal range.
- People taking antidepressant medication for depression must have been on a stable, unchanged dose for at least eight weeks before joining the study.
- People taking any psychiatric medications must agree to keep the same dose throughout the blinded phase of the study, if the treating doctor considers this medically appropriate.
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.
- There is evidence suggesting the person may have a different condition or a secondary cause of their Parkinson's-like symptoms, shown by any of the following signs:
- Unusual features appearing early in the illness, such as significant balance problems, freezing when walking, or hallucinations not caused by medication, occurring within the first three years of symptoms.
- Memory or thinking problems (dementia) that appeared before movement symptoms.
- Neurological signs pointing to upper motor neuron or cerebellar (balance and coordination centre of the brain) problems.
- Significant drops in blood pressure when standing up, not caused by medication.
- Loss of certain types of touch sensation or difficulty performing purposeful movements with the limbs, or progressive loss of language ability.
- Inability to move the eyes in certain directions, or abnormal slowing of eye movements downward or upward.
- Clear problems with balance or coordination linked to the cerebellum, such as an unsteady walking pattern, limb coordination problems, or abnormal eye movements like sustained uncontrolled eye movements.
- A condition known to cause Parkinson's-like symptoms that appears connected to the person's situation — for example, a brain scan showing significant shrinkage, small strokes, or iron deposits in a specific brain area; a history of stroke, toxin exposure, or brain infection; or use of certain psychiatric medications within the past six months.
- The specialist doctor, after a full assessment, believes a condition other than Parkinson's disease is the more likely diagnosis.
- The person has an uncontrolled medical condition or serious illness that would increase the risks of surgery or recovery, such as significant heart or lung disease or uncontrolled high blood pressure.
- The person shows signs of dementia, based on scoring below 123 on a standard rating scale.
- The person has been diagnosed with probable behavioural variant frontotemporal dementia or primary progressive aphasia (specific types of brain conditions affecting behaviour or language).
- The person currently has an active diagnosis of a major psychiatric disorder.
- The person has had a previous brain operation or brain injury.
- The person is currently taking part in another clinical trial for the treatment of Parkinson's disease.
- The person has a cardiac (heart) pacemaker or a medical condition that requires repeated MRI scans.
- The person already has involuntary movements (dyskinesia) related to their condition or medication.
- The person currently has a substance use disorder (such as problematic use of alcohol or drugs).
- The person has a history of recurring or unprovoked seizures (epilepsy).
- The person has previously had brain surgery or a device implanted inside the skull to treat a movement disorder.
- The person has any other active implanted device inside the skull (such as a cochlear implant) or an implanted device used to treat movement disorders (such as a duodopa pump), whether it is switched on or off.
- The person has a condition that currently requires, or is likely to require in the future, the use of MRI scans or a treatment called diathermy (which uses electromagnetic energy).
- The person has a history of a suicide attempt.
- A woman who is breastfeeding, pregnant (confirmed by a urine test), or of childbearing age and not using adequate contraception.
- The person is unwilling or unable to provide written informed consent.
- The person's Parkinson's-like symptoms have been limited only to the lower limbs for more than three years.
- The person has been treated with medications that block or deplete dopamine, in a way and timeframe consistent with those medications being the cause of their Parkinson's-like symptoms.
- A specialised brain scan (DaTSCAN) shows normal functioning of the dopamine system in the brain.
- The person's walking has deteriorated rapidly to the point of needing to use a wheelchair regularly.
- The person has early and significant problems with speaking or swallowing, such as speech that is mostly unintelligible, severe voice problems, or difficulty swallowing requiring a special diet or feeding tube.
- The person has breathing problems involving difficulty breathing in, such as noisy breathing when inhaling (stridor) or frequent involuntary sighing when breathing in.
- The person has fallen more than once per year due to balance problems within three years of symptoms starting.
- The person shows unexplained signs of damage to the main nerve pathways controlling movement, such as significant weakness or abnormal reflexes (apart from mild differences between sides of the body or a single abnormal toe reflex).
- The person's Parkinson's-like symptoms have been equally present on both sides of the body throughout the entire course of their illness, with no one side being more affected than the other, both as reported by the person or carer and as observed on examination.
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.
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
Phone: 1-615-875-7437
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
Mallory Hacker
Registry
ClinicalTrials.gov
Start date
1 January 2028
Est. completion
31 December 2032
Primary endpoints
frequency and severity of adverse events; frequency and severity of adverse cognitive outcome
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.