Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT07140302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgery of Dystonia
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
Stereotactic Surgical Management of Dystonia: Efficacy and Safety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: