Surgery of Dystonia

NCT07140302 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med-25-8-1MD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dystonia Stereotactic Surgery

Outcome Measures

Primary Outcomes (1)

• Improvement in Dystonia Severity (BFMDRS-Motor Score)

  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.

  From baseline (within 4 weeks prior to surgery) to the first postoperative week and up to 6 months postoperatively.

Study Arms (1)

stereotactic surgery of dystonia

EXPERIMENTAL

Patients with dystonia undergoing stereotactic surgical management (either Deep Brain Stimulation or Radiofrequency Lesioning), with choice of procedure determined by clinical indication.

Procedure: deep brain stimulation

Interventions

deep brain stimulation PROCEDURE

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

stereotactic surgery of dystonia

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculity of Medicine

Sohag, Egypt

Location

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

ahmrd mahmoud mostafa, assistant lecturer

CONTACT

01015566232; ahmed_mahmoud1@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecture

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

EG (1)