Parkinson's Disease Trial, Recruiting NCT02119611 Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT02119611
Recruiting Not Applicable

Who may 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 might be able to join this trial:

  • You are 18 years of age or older.
  • You are able to follow the study procedures and agree to take part by signing a consent form.
  • You have been diagnosed with Parkinson's disease (PD), a form of dystonia (a movement disorder causing involuntary muscle contractions), or essential tremor (ET — a condition causing uncontrollable shaking), confirmed by specialist doctors.
  • If you have Parkinson's disease, your symptoms have improved by at least 30% with Parkinson's medication in the past or during a clinic test, OR you have tremor-dominant Parkinson's that does not respond to medication but your tremor is at least a moderate level on at least one side of your body (confirm with trial site).
  • Your symptoms have not been well controlled despite trying different doses of medications, including: for Parkinson's — medication helps but doesn't last long enough or causes unacceptable side effects, or you have severe "off" periods, uncontrolled movements, or freezing; for essential tremor or dystonia — your symptoms affect at least 2 everyday activities.
  • You are interested in being assessed for a brain stimulation device called Deep Brain Stimulation (DBS) to treat your movement disorder, OR you already have a DBS device implanted and need ongoing management.

Who may not be able to join:

  • You have a serious medical condition that could increase the risk of complications before or after surgery, such as very high uncontrolled blood pressure (above 170/100), unstable heart or breathing problems, or blood clotting issues that cannot be safely managed.
  • There are signs that your movement disorder may be caused by something other than the primary diagnosis, such as a history of stroke, certain medications, toxins, or brain infection, or brain scan findings showing a tumour or stroke as a possible cause.
  • You have been found to have significant memory or thinking problems (dementia), based on formal testing and clinical assessment.
  • You are unable to complete the thinking and memory tests needed to properly assess the risks and benefits of surgery.
  • You have a significant or unstable mental health condition, such as severe depression or anxiety, that the research team believes would increase the risk of complications after surgery.
  • You are unable to have an MRI scan — for example, because you have a pacemaker, certain metal implants, aneurysm clips, a medication pump, cochlear implants, permanent eyeliner, metal fragments in your eyes, or because you feel very uncomfortable in small enclosed spaces (claustrophobia), or cannot lie still on your back for up to one hour.
  • You are pregnant.
  • You are not suitable for DBS surgery for any other reason, such as being unable to have anaesthesia.
  • If you already have a DBS device, you are experiencing side effects from the stimulation that cannot be resolved by adjusting the device settings.

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 12 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.

Contact this trial

Principal Investigator: Debra J Ehrlich, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Phone: (301) 402-4479

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
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
2 April 2014
Est. completion
1 December 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To provide DBS therapy and follow-up management; To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology; Data collection

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: 12 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