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Clinical Trials in Egypt / NCT07140302
Starting soon Not applicable

Surgery of Dystonia

NCT07140302 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sohag University
Phase
Not applicable
Started
2025-09-01
Last updated
2025-08-24

Condition(s) studied

Dystonia Stereotactic Surgery

Investigational drug(s) / intervention(s)

deep brain stimulation

deep brain stimulation: Stereotactic implantation of DBS electrodes with chronic electrical stimulation of target nuclei for dystonia. or Stereotactic radiofrequency ablation of dystonia-related target nuclei.

Study summary

The goal of this clinical trial is to evaluate the safety and clinical outcomes of stereotactic surgery (Deep Brain Stimulation or Radiofrequency Lesioning) in patients with dystonia.

The main questions it aims to answer are:

* Does stereotactic surgery improve dystonia severity as measured by the Burke-Fahn-Marsden Dystonia Rating Scale - Motor (BFMDRS-M)?
* Are the procedures safe, with an acceptable complication profile during follow-up?

Participants will:

* Undergo stereotactic surgery for dystonia (either Deep Brain Stimulation or Radiofrequency Lesioning, based on clinical indication).
* Be followed postoperatively for assessment of motor function and adverse events at the first postoperative week and six months after surgery.

Eligibility

Sex
ALL
Min age
10 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosed with dystonia with at least 1-year duration since symptom onset. * Inadequate relief of dystonia following treatment with standard pharmacotherapies (e.g., levodopa, clonazepam, trihexyphenidyl, or baclofen) or botulinum toxin injections. Exclusion Criteria: * Previous DBS surgery. * Underwent DBS combined with another surgical procedure for dystonia (e.g., lesioning or peripheral denervation). * Cognitive dysfunction or other neuropsychiatric disorders. * Progressive neurological conditions other than dystonia. * Coagulopathy or bleeding disorders.

Primary outcome measure(s)

  • Improvement in Dystonia Severity (BFMDRS-Motor Score) — From baseline (within 4 weeks prior to surgery) to the first postoperative week and up to 6 months postoperatively.
    Change in motor severity of dystonia as assessed by the Burke-Fahn-Marsden Dystonia Rating Scale - Motor Subscale (BFMDRS-M; range 0-120, higher scores = worse dystonia). The primary endpoint is the percent change from baseline to follow-up.

Trial sites (1)

FacilityCityRegionStatus
Sohag Faculity of Medicine Sohag Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07140302 on ClinicalTrials.gov ↗ ← All trials in Egypt