Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Medtronic Activa Tremor Control System for Parkinson's Disease

Background: \- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest.

Official registry: https://clinicaltrials.gov/study/NCT01581580 · National Institute of Neurological Disorders and Stroke (NINDS) · enrollment listed as 200

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Medtronic Activa Tremor Control System, or Deep Brain Stimulation. The registry lists allocation as na. Background: \- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments.

They plan to enroll about 200 people at Bethesda. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Deep Brain Stimulation Surgery for Movement Disorders

Interventions: Medtronic Activa Tremor Control System, Deep Brain Stimulation

Primary outcome (registry wording): physiology and efficacy of DBS surgery for movement disorders

Who it is for (from inclusion criteria)

  • Ages 18 Years to 99 Years
  • To be eligible for entry into the study, candidates must meet all the following criteria:
  • Be 18 years of age or older
  • Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:
  • idiopathic PD not adequately controlled with medication or
  • primary dystonia that is medically refractory, or
  • ET that is not adequately controlled by medications or constitutes a significant functional disability

Public study contact (from the registry)

Sharon C Park

(301) 496-2921

sharon.park@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT01581580 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT01581580?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT01581580?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary