Dystonic TremorPSA-STNNCT06752434
PSA Versus STN DBS for DT
A study testing Deep brain stimulation in people with Dystonic Tremor, run by Ruijin Hospital at 1 site in China.
Trial summary
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dystonic Tremor
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Mar 2029
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with dystonic tremor based on the MDS 2018 consensus
- Duration of DT symptoms: ≥3 years of motor symptoms
- If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
- Good compliance and written informed consent
Who cannot join
- Any intracranial abnormalities that would prevent DBS surgery
- Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
- Severe cognitive impairment, MOCA score <24
- Any current substance or alcohol abuse according to DSM-V criteria
- Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints
- Any terminal illness with a life expectancy of <1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Dianyou Li, MD,PhD, +0086-021-64370045, ldy11483@rjh.com.cn
About this study
Official title: Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: a Prospective, Randomized, Double-blinded, Cross-over Trial
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.
Read the detailed description
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating dystonic tremor. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
- Conditions
- Dystonic Tremor
- Being tested
- Deep brain stimulation
- Keywords
- Dystonic Tremor, deep brain stimulation, posterior subthalamic area, subthalamic nucleus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
active DBS with optimal stimulating parameters
| Study group | Role | What they receive |
|---|---|---|
| PSA-STN | Experimental | Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months. Receives: Device: Deep brain stimulation |
| STN-PSA | Experimental | Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months
Measured: 5 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months
Measured: 7 months
Secondary outcomes (7)
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months
Measured: 5 months
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months
Measured: 7 months
Change from baseline Mini-Mental Status Exam to 5 months
Measured: 5 months
Change from baseline Mini-Mental Status Exam to 7 months
Measured: 7 months
Change from baseline Beck depression inventory to 5 months
Measured: 5 months
Change from baseline Beck depression inventory to 7 months
Measured: 7 months
Adverse events
Measured: up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystonic TremorStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd, Beijing Pins Medical Co., Ltd
- Responsible party
- Principal investigator, LI DIANYOU, Ruijin Hospital
- Investigators
- Dianyou Li, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752434
- Sponsor's protocol ID
- DTPSASTN
- Acronym
- PSA-STN
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Dystonic Tremor: a Prospective, Randomized, Double-blinded, Cross-over Trial
- ClinicalTrials.gov ID
- NCT06752434
- Acronym / sponsor ID
- PSA-STN / DTPSASTN
- Conditions
- Dystonic Tremor
- Keywords
- Dystonic Tremor, deep brain stimulation, posterior subthalamic area, subthalamic nucleus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd, Beijing Pins Medical Co., Ltd
- Study start
- Dec 2024 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 30 Dec 2024 (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 aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dystonic tremor (DT) in a randomized, double-blinded, cross-over manner.
Detailed description
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating dystonic tremor. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSA-STN | Experimental | Device: Deep brain stimulationParticipants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months. |
| STN-PSA | Experimental | Device: Deep brain stimulationParticipants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with dystonic tremor based on the MDS 2018 consensus
- Duration of DT symptoms: ≥3 years of motor symptoms
- If the patient is taking tremor medications, the medications should be stable for 28 days prior to informed consent
- Good compliance and written informed consent
Key exclusion criteria (6 listed)
- Any intracranial abnormalities that would prevent DBS surgery
- Any significant mental illness that might affect the subject's ability to comply with the study protocol requirements (e.g., bipolar disorder, schizophrenia, mood disorders with psychotic features, Cluster B personality disorders)
- Severe cognitive impairment, MOCA score <24
- Any current substance or alcohol abuse according to DSM-V criteria
- Any history of recurrent or unprovoked epileptic seizures; any prior movement disorder treatment involving intracranial surgery or device implantation; any history of hemorrhagic stroke; any significant medical condition that might interfere with the study procedures or could confound the assessment of study endpoints
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 stimulationactive DBS with optimal stimulating parameters | Device | PSA-STN, STN-PSA |
Primary outcome
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months
Time frame: 5 months
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months
Time frame: 7 months
7 secondary outcomes
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 5 months
Time frame: 5 months
Change from baseline Burke-Fahn-Marsden Dystonia Rating Scale to 7 months
Time frame: 7 months
Change from baseline Mini-Mental Status Exam to 5 months
Time frame: 5 months
Change from baseline Mini-Mental Status Exam to 7 months
Time frame: 7 months
Change from baseline Beck depression inventory to 5 months
Time frame: 5 months
Change from baseline Beck depression inventory to 7 months
Time frame: 7 months
Adverse events
Time frame: up to 12 months after surgery
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 30 Dec 2024.
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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.
Dianyou Li, MD, PhD 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 Dystonic Tremor, 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. 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. 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 Dianyou Li, MD, PhD (+0086-021-64370045, ldy11483@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months (time frame: 5 months). The study lists 2 primary outcomes in all. 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 30 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.