Surgery of Dystonia

NCT ID: NCT07140302

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-01

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.

Detailed Description

Detailed Description

Dystonia is a chronic movement disorder characterized by sustained or intermittent muscle contractions, resulting in abnormal postures, repetitive movements, and functional disability. Medical therapy often provides limited benefit, particularly in patients with severe or refractory forms of dystonia.

Stereotactic surgical approaches, including Deep Brain Stimulation (DBS) and Radiofrequency (RF) lesioning, have emerged as effective treatment options for carefully selected patients. DBS offers a reversible and adjustable method of neuromodulation, while RF lesioning provides a less resource-intensive option in settings where DBS may not be feasible.

The purpose of this study is to evaluate the clinical outcomes and safety of stereotactic surgical management in patients with dystonia treated at our center. All enrolled participants will undergo stereotactic surgery-either DBS implantation or RF lesioning-based on clinical indications and multidisciplinary decision-making.

Patients will be assessed preoperatively and followed postoperatively at standardized intervals, including the first postoperative week and at six months. The primary outcome is the change in dystonia severity as measured by the Burke-Fahn-Marsden Dystonia Rating Scale - Motor Subscale (BFMDRS-M). Secondary outcomes will include functional disability, quality of life, and perioperative complications.

This study is designed as a prospective interventional case series without a formal control group, aiming to provide real-world outcome data on the effectiveness and safety of stereotactic surgical management of dystonia

Conditions

Dystonia Stereotactic Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

stereotactic surgery of dystonia

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

Group Type: EXPERIMENTAL

deep brain stimulation

Intervention Type: PROCEDURE

Stereotactic implantation of DBS electrodes with chronic electrical stimulation of target nuclei for dystonia.

or Stereotactic radiofrequency ablation of dystonia-related target nuclei.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mahmoud Mostafa

assistant lecture

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag Faculity of Medicine

Sohag, , Egypt

Countries

Egypt

Central Contacts

ahmrd mahmoud mostafa, assistant lecturer

Role: CONTACT

ahmed_mahmoud1@med.sohag.edu.eg

01015566232

Other Identifiers

Soh-Med-25-8-1MD

Identifier Type: -

Identifier Source: org_study_id