Dystonia Stereotactic SurgeryNCT07140302
Surgery of Dystonia
A study testing deep brain stimulation in people with Dystonia Stereotactic Surgery, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Dystonia Stereotactic Surgery
- What is being tested?
- deep brain stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Stereotactic Surgical Management of Dystonia: Efficacy and Safety
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:
Read more
- 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.
Read the 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
- Being tested
- deep brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationProcedure or surgery
Stereotactic implantation of DBS electrodes with chronic electrical stimulation of target nuclei for dystonia.
or Stereotactic radiofrequency ablation of dystonia-related target nuclei.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (within 4 weeks prior to surgery) to the first postoperative week and up to 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystonia Stereotactic SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Mostafa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140302
- Sponsor's protocol ID
- Soh-Med-25-8-1MD
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: may be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Surgical Management of Dystonia: Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07140302
- Acronym / sponsor ID
- Soh-Med-25-8-1MD
- Conditions
- Dystonia Stereotactic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stereotactic surgery of dystonia | Experimental | Procedure: deep brain stimulationPatients with dystonia undergoing stereotactic surgical management (either Deep Brain Stimulation or Radiofrequency Lesioning), with choice of procedure determined by clinical indication. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep brain stimulationStereotactic implantation of DBS electrodes with chronic electrical stimulation of target nuclei for dystonia. or Stereotactic radiofrequency ablation of dystonia-related target nuclei. | Procedure or surgery | stereotactic surgery of dystonia |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided. may be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep brain stimulation in people with Dystonia Stereotactic Surgery, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmrd mahmoud mostafa, assistant lecturer (01015566232, ahmed_mahmoud1@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.