CompletedNot Applicable

Efficacy and Safety of DBS in Patients With Primary Dystonia

China72 participantsStarted 2017-12-27

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for primary dystonia.

Who can participate

Age range6 Years – 60 Years

SexALL

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Inclusion criteria

✓. Refractory primary (systemic, segmental) dystonia diagnosed by a movement disorders neurologist
✓. Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
✓. Ability to follow up with post-operative study visits
✓. Patients and their relatives have reasonable surgery expectations
✓. Volunteer to participate in clinical trials, and signed consent form
✓. Age 6-60 years

Exclusion criteria

✕. Pregnancy or plan a pregnancy
✕. Good treatment with Non-invasive therapy
✕. Dopamine reactive dystonia ，Genetic degeneration ，Paroxysmal dystonia ，Secondary dystonia， Psychogenic dystonia
✕. Brain MRI showing extensive brain atrophy or small vessel ischemic disease
✕. Cognitive impairment(MMSE\<24)
✕. Severe depression or other serious mental illness
✕. History of traumatic brain injury, tumor, or severe cerebrovascular disease
✕. Severe brain atrophy (diagnosed by CT or MRI)

What they're measuring

change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score

Timeframe: 3，6 months

Trial details

NCT IDNCT03017586

SponsorBeijing Pins Medical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-09-13

View on ClinicalTrials.gov More Dystonia trials