DystoniaSUNDYSNCT04650958
SUNDYS: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
A study testing Deep brain stimulation in people with Dystonia, run by Ruijin Hospital at 1 site in China.
Trial summary
Dystonia is a group of movement disorders characterized by twisting, repetitive movements, or abnormal postures caused by involuntary muscle contractions and is characterized by a young age of onset and a high disability rate. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Dystonia
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet criteria for the diagnosis of isolated generalized or segmental dystonia, including idiopathic and inherited dystonia, as defined by the Phenomenology and Classification of Dystonia: A Consensus Update 2013;
- Patients will be ≥ 14 years old;
- The course of disease will be ≥ 3 years;
- Patients will have:
- Significant dystonia symptoms;
- Compromised life quality;
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- Unsatisfactory response to oral treatment with anticholinergic agents antiepileptic agents, anti-dopamine agents, dopaminergic agents, or muscle relaxants;
- Unsatisfactory response to or contraindication for previous botulinum toxin treatment; and
- Ability to provide written informed consent.
Who cannot join
- Patients with a diagnosis or probable diagnosis of acquired, compound, and complex dystonia, as defined by the Phenomenology and Classification of Dystonia: A Consensus Update 2013;
- Previous brain surgery for dystonia;
- Patients with cognitive impairment (MMSE score <24) or moderate-severe depressive disorder (BDI>25);
- Patients with marked brain atrophy identified by magnetic resonance imaging (MRI) or computed tomography (CT);
- Patients with other medical or psychiatric comorbidities that could increase the surgical risk or interfere with completion of the trial;
- Patients with increased bleeding risk, or other factors contraindicating neurosurgery or general anesthesia;
- Patients unable to cooperate with the assessments during the follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Kejia Hu, MD,PhD, +86 18930113801, dockejiahu@gmail.com
About this study
Official title: Subthalamic Nucleus Deep Brain Stimulation in Isolated Generalized or Segmental Dystonia: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
Dystonia is a group of movement disorders characterized by twisting, repetitive movements, or abnormal postures caused by involuntary muscle contractions and is characterized by a young age of onset and a high disability rate. Early intervention can reduce disability incidence, improve the patient's quality of life, and reduce the burden on families and society. Multiple international guidelines on dystonia have found deep brain stimulation (DBS) to be a safe and effective treatment for refractory dystonia. The globus pallidal internus (GPi) is the mostly widely used target for dystonia. However, there are limitations on the GPi DBS treatment, including slow onset of beneficial effects, poor improvement of axis symptoms, and potential stimulation-related side effects. Previous studies have described the highly successful use of subthalamic nucleus deep brain stimulation (STN DBS) in patients with refractory dystonia, suggesting that STN DBS is an effective and persisting alternative to pallidal deep brain stimulation. However, all STN DBS treated cases have been analyzed in open-label uncontrolled cohort studies, leading to limited data with a high level of evidence on the STN DBS in dystonia. Further, the investigators hypothesized STN has potentially more effectiveness when compared with GPi, and may be more power-saving and quick-acting. In this study, the investigators will organize a prospective randomized, double-blind, parallel-group, multicenter study comparing active versus sham stimulation in isolated segmental or generalized dystonia to evaluate the effectiveness and safety of STN DBS by measuring the impact on motor status, mental status, quality of life, the rate of response of the patients (the number of patients with ≥30% improvement in the movement score on the Burke-Fahn-Marsden Dystonia Rating Scale) and the rate of adverse events during the trial.
- Conditions
- Dystonia
- Being tested
- Deep brain stimulation
- Keywords
- Deep brain stimulation, Subthalamic nucleus, Randomized controlled trial
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
Deep brain stimulation (DBS) has been in use to treat patients with movement disorders since 1989, with many thousands of publications showing its effectiveness. DBS for dystonia received the US FDA mark in 2003 and China FDA mark in 2016. In this study, the DBS system devices are manufactured and donated by SceneRay (Suzhou, China). The Stimulator System is implanted by a qualified neurosurgeon and consists of three implantable components: the leads, the extension wires and the neurostimulator. The DBS programming will start within 1 week after the surgery completed.
| Study group | Role | What they receive |
|---|---|---|
| STN DBS stimulation group | Active comparator | In the STN DBS stimulation group, patients will receive a continuous DBS stimulation for 3 months and the first default parameters applied will be monopolar setting (0.5 V under threshold that causes side effects, 135 Hz, 90 µs, at one of the two dorsal contacts). If the default parameters are found not suitable for an individual patient due to unexpected reasons, an alternative method will be applied (e.g., decreased voltage) to try to maintain full compliance with the scheduled study. Receives: Procedure: Deep brain stimulation |
| Sham stimulation group | Sham comparator | In the sham stimulation group, the programming will also start within 1 week after the surgery, but at each follow-up the DBS system will be turned off after the parameter is adjusted to the threshold that causes side effects without continuous stimulation. After the 3-month double-blind period the patients can choose to set on the DBS system again and receive regular continuous stimulation treatment. Receives: Procedure: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline to 3 months after stimulation of Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) score
The scale consists of a movement and disability subscale with scores ranging from 0 to 120 and 0 to 30, respectively, higher scores indicating greater impairment.
Measured: Baseline; 3months after stimulation
Secondary outcomes (9)
Abnormal Involuntary Movement Scale (AIMS)
The AIMS is a 12-item clinician-rated scale to assess severity of dyskinesias. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the 12 items refer to dental care.
Measured: Baseline; 1 week, 1 month and 3months after stimulation
36-item Short-Form General Health survey (SF-36)
SF-36 is a measure of health-related quality-of-life with a 36-item patient-reported questionnaire that covers eight health domains. Higher scores indicate a more favorable health state.
Measured: Baseline; 1 week, 1 month and 3months after stimulation
Beck Depression Inventory-II (BDI)
BDI contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
Measured: Baseline; 1 week, 1 month and 3months after stimulation
Beck Anxiety Inventory (BAI)
BAI contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe anxiety symptoms.
Measured: Baseline; 1 week, 1 month and 3months after stimulation
Montreal Cognitive Assessment (MoCA)
MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal. Lower scores indicate more disability.
Measured: Baseline; 3months after stimulation
Cambridge Neuropsychological Test Automated Battery (CANTAB)
A detailed computerized cognitive battery selected from CANTAB includes: Stockings of Cambridge (SOC) and Spatial working memory (SWM) for executive function; Motor screening task (MOT) and a five-choice series selection task for attention; Paired associates learning (PAL) and Pattern recognition memory (PRM) for memory.
Measured: Baseline; 3months after stimulation
The rate of response
The number of patients with ≥30% improvement in the movement score on the BFMDRS
Measured: 1 week, 1 month and 3months after stimulation
The rate of adverse event (AE)
Measured: Within 1 week after surgery; 1 week, 1 month and 3months after stimulation
Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS)
The scale consists of a movement and disability subscale with scores ranging from 0 to 120 and 0 to 30, respectively, higher scores indicating greater impairment.
Measured: 1 week and 1 month after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study after having DBS leads implanted successfully, 38 patients will be randomly assigned to either the control or experimental group with a 1:1 allocation. The experimental group will receive continuous DBS stimulation for 3 months, while controls will have sham stimulation for 3 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Shanghai Tongji Hospital, Tongji University School of Medicine, Second Affiliated Hospital of Soochow University, West China Hospital
- Responsible party
- Principal investigator, Bomin Sun, Ruijin Hospital
- Investigators
- Bomin Sun, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650958
- Sponsor's protocol ID
- Ruijin_SUNDYS
- Acronym
- SUNDYS
- Status last verified
- Apr 2021
- First submitted
- 19 Nov 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu K, Wu Y, Shen T, Zhou J, Li H, Dong H, Yi W, Luo C, Jin L, Liu C, Shang H, Zhan S, Li D, Wu Y, Benabid AL, Sun B; SUNDYS investigators. Effectiveness and safety of subthalamic nucleus deep brain stimulation in isolated generalised or segmental dystonia (SUNDYS trial): a study protocol. Br J Neurosurg. 2026 Jun;40(3):446-454. doi: 10.1080/02688697.2025.2562277. Epub 2025 Sep 22.
PubMed 40981502
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthalamic Nucleus Deep Brain Stimulation in Isolated Generalized or Segmental Dystonia: A Multicenter, Randomized, Double-blind, Sham-controlled, Parallel-group Trial
- ClinicalTrials.gov ID
- NCT04650958
- Acronym / sponsor ID
- SUNDYS / Ruijin_SUNDYS
- Conditions
- Dystonia
- Keywords
- Deep brain stimulation, Subthalamic nucleus, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Shanghai Tongji Hospital, Tongji University School of Medicine, Second Affiliated Hospital of Soochow University, West China Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 3 Dec 2020 (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.
Dystonia is a group of movement disorders characterized by twisting, repetitive movements, or abnormal postures caused by involuntary muscle contractions and is characterized by a young age of onset and a high disability rate. Early intervention can reduce disability incidence, improve the patient's quality of life, and reduce the burden on families and society. Multiple international guidelines on dystonia have found deep brain stimulation (DBS) to be a safe and effective treatment for refractory dystonia. The globus pallidal internus (GPi) is the mostly widely used target for dystonia. However, there are limitations on the GPi DBS treatment, including slow onset of beneficial effects, poor improvement of axis symptoms, and potential stimulation-related side effects. Previous studies have described the highly successful use of subthalamic nucleus deep brain stimulation (STN DBS) in patients with refractory dystonia, suggesting that STN DBS is an effective and persisting alternative to pallidal deep brain stimulation. However, all STN DBS treated cases have been analyzed in open-label uncontrolled cohort studies, leading to limited data with a high level of evidence on the STN DBS in dystonia. Further, the investigators hypothesized STN has potentially more effectiveness when compared with GPi, and may be more power-saving and quick-acting. In this study, the investigators will organize a prospective randomized, double-blind, parallel-group, multicenter study comparing active versus sham stimulation in isolated segmental or generalized dystonia to evaluate the effectiveness and safety of STN DBS by measuring the impact on motor status, mental status, quality of life, the rate of response of the patients (the number of patients with ≥30% improvement in the movement score on the Burke-Fahn-Marsden Dystonia Rating Scale) and the rate of adverse events during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study after having DBS leads implanted successfully, 38 patients will be randomly assigned to either the control or experimental group with a 1:1 allocation. The experimental group will receive continuous DBS stimulation for 3 months, while controls will have sham stimulation for 3 months.
| Arm | Type | Receives |
|---|---|---|
| STN DBS stimulation group | Active comparator | Procedure: Deep brain stimulationIn the STN DBS stimulation group, patients will receive a continuous DBS stimulation for 3 months and the first default parameters applied will be monopolar setting (0.5 V under threshold that causes side effects, 135 Hz, 90 µs, at one of the two dorsal contacts). If the default parameters are found not suitable for an individual patient due to unexpected reasons, an alternative method will be applied (e.g., decreased voltage) to try to maintain full compliance with the scheduled study. |
| Sham stimulation group | Sham comparator | Procedure: Deep brain stimulationIn the sham stimulation group, the programming will also start within 1 week after the surgery, but at each follow-up the DBS system will be turned off after the parameter is adjusted to the threshold that causes side effects without continuous stimulation. After the 3-month double-blind period the patients can choose to set on the DBS system again and receive regular continuous stimulation treatment. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must meet criteria for the diagnosis of isolated generalized or segmental dystonia, including idiopathic and inherited dystonia, as defined by the Phenomenology and Classification of Dystonia: A Consensus Update 2013;
- Patients will be ≥ 14 years old;
- The course of disease will be ≥ 3 years;
- Patients will have:
Key exclusion criteria (7 listed)
- Patients with a diagnosis or probable diagnosis of acquired, compound, and complex dystonia, as defined by the Phenomenology and Classification of Dystonia: A Consensus Update 2013;
- Previous brain surgery for dystonia;
- Patients with cognitive impairment (MMSE score <24) or moderate-severe depressive disorder (BDI>25);
- Patients with marked brain atrophy identified by magnetic resonance imaging (MRI) or computed tomography (CT);
- Patients with other medical or psychiatric comorbidities that could increase the surgical risk or interfere with completion of the trial;
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 stimulationDeep brain stimulation (DBS) has been in use to treat patients with movement disorders since 1989, with many thousands of publications showing its effectiveness. DBS for dystonia received the US FDA mark in 2003 and China FDA mark in 2016. In this study, the DBS system devices are manufactured and donated by SceneRay (Suzhou, China). The Stimulator System is implanted by a qualified neurosurgeon and consists of three implantable components: the leads, the extension wires and the neurostimulator. The DBS programming will start within 1 week after the surgery completed. | Procedure or surgery | STN DBS stimulation group, Sham stimulation group |
Primary outcome
The change from baseline to 3 months after stimulation of Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) score
Time frame: Baseline; 3months after stimulation
The scale consists of a movement and disability subscale with scores ranging from 0 to 120 and 0 to 30, respectively, higher scores indicating greater impairment.
9 secondary outcomes
Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline; 1 week, 1 month and 3months after stimulation
36-item Short-Form General Health survey (SF-36)
Time frame: Baseline; 1 week, 1 month and 3months after stimulation
Beck Depression Inventory-II (BDI)
Time frame: Baseline; 1 week, 1 month and 3months after stimulation
Beck Anxiety Inventory (BAI)
Time frame: Baseline; 1 week, 1 month and 3months after stimulation
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline; 3months after stimulation
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline; 3months after stimulation
The rate of response
Time frame: 1 week, 1 month and 3months after stimulation
The rate of adverse event (AE)
Time frame: Within 1 week after surgery; 1 week, 1 month and 3months after stimulation
Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS)
Time frame: 1 week and 1 month after stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 40981502Hu K, Wu Y, Shen T, Zhou J, Li H, Dong H, Yi W, Luo C, Jin L, Liu C, Shang H, Zhan S, Li D, Wu Y, Benabid AL, Sun B; SUNDYS investigators. Effectiveness and safety of subthalamic nucleus deep brain stimulation in isolated generalised or segmental dystonia (SUNDYS trial): a study protocol. Br J Neurosurg. 2026 Jun;40(3):446-454. doi: 10.1080/02688697.2025.2562277. Epub 2025 Sep 22.
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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. This study is not recruiting at the moment.
Bomin Sun principal investigator
Ruijin Hospital
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, run by Ruijin Hospital at 1 site in China.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Apr 2021. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kejia Hu, MD, PhD (18930113801, dockejiahu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline to 3 months after stimulation of Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) score (time frame: Baseline; 3months after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650958, which also lists 1 linked publication.
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 8 Apr 2021.