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NCT03078816 · ClinicalTrials.gov registry record · NA
Thalamic Deep Brain Stimulation for Secondary Dystonia in Children and Young Adults
A NA study of Dystonia, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03078816: Completed NA study of Dystonia, sponsored by University of California, San Francisco.
NCT03078816 is a NA study of Dystonia that has completed, run by University of California, San Francisco. The registered enrollment target is 5 participants, below the 540-participant average among 28 other Dystonia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078816, a NA study of Dystonia, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
Dystonia is a movement disorder seen in both children and adults that is characterized by "sustained or intermittent muscle contractions causing abnormal, often repetitive, movements, postures, or both." Secondary dystonia is far more common in pediatric populations than primary dystonia, and far more recalcitrant to standard pharmacologic and surgical treatments including Deep Brain Stimulation (DBS). There exists a large unmet need to develop new therapeutics, treatment strategies, and outcome measures for pediatric secondary dystonia. The investigators are proposing to investigate the ventralis oralis posterior nucleus (Vop) of the thalamus as a new target for DBS in secondary dystonia. Prior to the development of DBS, the main surgical treatment of dystonia was thalamotomy. Although there were many different targets in the thalamus, often done in staged procedures, the most common and successful targeted nuclei was the Vop, which is traditionally thought to be the pallidal receiving area. Previous lesioning of Vop produced improvements in dystonia but intolerable side effects, especially when implanted bilaterally. However, given that secondary dystonia patients were often reported to have superior results to primary dystonia it is reasonable to believe that if the side effects can be modulated, that targeting of the Vop nucleus with DBS could be a viable alternative to Globus Pallidus interna (GPi). Given that Deep Brain Stimulation is a treatment that is inherently adjustable, it is conceivable that settings on the Deep Brain Stimulation could be adjusted to allow for clinical benefit with minimal side effects. Indeed, there have been several scattered successful case reports attesting to this possibility.
Primary Outcome
Rating scale that measures movement and disability related to dystonia, range 0-120 motor, 0-30 disability , higher number indicates more severe dystonia Change from Baseline in Burke-Fahn-Marsden Dystonia Rating Scale
Conditions Studied
Interventions
- DEVICE Activa PC Primary Cell Neurostimulator - (Model 37601)
- DEVICE Activa RC Rechargeable Neurostimulator - (Model 37612)
- DEVICE Activa SC Single Cell Neurostimulator (Models 37602/37603)
- DEVICE DBS Lead - (Model 3387
- DEVICE DBS Extension - (Models 37085/6)
Study Locations (1)
California
- University of California San Francisco Hospital - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-03-03 |
| Est. Completion | 2019-07-24 |
| Phase | NA |
What the finished NCT03078816 record still lists
NCT03078816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 540-participant average among 28 other Dystonia trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Dystonia appearing as the primary indexed condition, and to 5 interventions - of which Activa PC Primary Cell Neurostimulator - (Model 37601) is the first listed.
NCT03078816 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03078816 about?
NCT03078816 is a clinical study titled "Thalamic Deep Brain Stimulation for Secondary Dystonia in Children and Young Adults". Dystonia is a movement disorder seen in both children and adults that is characterized by "sustained or intermittent muscle contractions causing abnormal, often repetitive, movements, postures, or both." Secondary dystonia is far more common in pediatric populations than primary dystonia, and far mo...
What is the current status of trial NCT03078816?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2017-03-03. Estimated completion is 2019-07-24.
What conditions does trial NCT03078816 study?
This clinical trial studies the following conditions: Dystonia.
What interventions are being tested in trial NCT03078816?
The interventions under investigation include: Activa PC Primary Cell Neurostimulator - (Model 37601) (DEVICE), Activa RC Rechargeable Neurostimulator - (Model 37612) (DEVICE), Activa SC Single Cell Neurostimulator (Models 37602/37603) (DEVICE), DBS Lead - (Model 3387 (DEVICE), DBS Extension - (Models 37085/6) (DEVICE).
Who is sponsoring clinical trial NCT03078816?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03078816 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dystonia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03078816's enrollment target sits among peer trials
5 28th of 28 the lowest of 28 other Dystonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dystonia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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