Clinical Trial Details
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NCT03078816 : Thalamic Deep Brain Stimulation for Secondary Dystonia in Children and Young Adults
PhasePhase 1
AgesMin: 7 Years Max: 25 Years
Inclusion Criteria:

1. Ability to give informed consent or assent for the study

2. Dystonia symptoms that are sufficiently severe, in spite of best medical therapy, to
warrant surgical implantation of deep brain stimulators according to standard
clinical criteria

3. Age 7-25

4. Stable doses of anti-dystonia medications (such as levodopa, baclofen, or diazepam)
for at least 30 days prior to baseline assessment

5. If patient receives botulinum toxin injections, patient should be on a stable
injection regimen

6. Intact thalamic anatomy as determined by standard clinical MRI

Exclusion Criteria:

1. Pregnancy or breast feeding

2. Major comorbidity increasing the risk of surgery (severe hypertension, severe
diabetes, or need for chronic anticoagulation other than aspirin)

3. Inability to comply with study follow-up visits

4. Any prior intracranial surgery

5. Uncontrolled epilepsy

6. Immunocompromised

7. Has an active infection

8. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic
stimulation (TMS) to treat a chronic condition

9. Has an existing implanted neurostimulator or cardiac pacemaker.

10. Dystonia caused by known genetic mutation in any DYT genes
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