Parkinson's Disease Trial, Recruiting NCT04116996 Sponsor: Mayo Clinic Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT04116996
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:

  • People who are between 40 and 80 years old
  • People who have been experiencing Parkinson's symptoms for between 7 and 20 years
  • People who have severe insomnia, based on a specific insomnia questionnaire score (called the ISI)

Who may not be able to join:

  • People with significant memory or thinking problems (a score below 23 on a standard cognitive test)
  • People whose Parkinson's disease is at the mildest or most severe stage on a standard rating scale (stage I or stage V on the Hoehn & Yahr scale)
  • People with another serious neurological or mental health condition
  • People who have previously had certain brain surgeries (pallidotomy or thalamotomy)
  • People who have previously had other implanted medical devices placed in the body
  • People whose Parkinson's-like symptoms are caused by something other than Parkinson's disease itself (sometimes called secondary or non-idiopathic parkinsonism)
  • People who are unable to travel to Jacksonville, Florida for follow-up visits after the procedure
  • People with severe sleep apnea
  • People whose insomnia is caused by pain or an untreated mood disorder
  • People who are unable to have a 3 Tesla (3T) MRI scan, for any medical reason
  • People with a sleep disorder related to the body's internal clock (circadian rhythm disorders)
  • People who are currently taking sleeping medication (hypnotics)

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 26 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
1 January 2019
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Insomnia Severity Index

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: 26 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