Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT06752434
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with dystonic tremor based on the MDS 2018 consensus
* Duration of DT symptoms: ≥3 years of motor symptoms
* If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
* Good compliance and written informed consent
Exclusion Criteria:
* Any intracranial abnormalities that would prevent DBS surgery
* Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
* Severe cognitive impairment, MOCA score \<24
* Any current substance or alcohol abuse according to DSM-V criteria
* Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints
* Any terminal illness with a life expectancy of \<1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06752434
Study Brief:
Protocol Section:
NCT06752434