Surgery of Dystonia

Official title

Stereotactic Surgical Management of Dystonia: Efficacy and Safety

Overview

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

Interventions

• Procedure 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.

Primary outcome measures

• Improvement in Dystonia Severity (BFMDRS-Motor Score) [Time frame: From baseline (within 4 weeks prior to surgery) to the first postoperative week and up to 6 months postoperatively.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Sohag Faculity of Medicine — Sohag

Identifiers

NCT: NCT07140302 · Soh-Med-25-8-1MD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗