DystoniaNCT06480188
Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation in the Treatment of Craniocervical Dystonia
A study testing deep brain stimulation in people with Dystonia, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Craniocervical dystonia, characterized by symptoms distributed in the craniofacial and/or cervical regions, is a type of focal or segmental dystonia and is the most common form of dystonia in adults. Deep brain stimulation (DBS) is a significant therapeutic approach for medically refractory craniocervical dystonia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dystonia
- 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Mar 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Meeting the diagnostic criteria for primary craniocervical dystonia (including patients with cranial, cervical, or unilateral extremity dystonia)
- Disease duration ≥1 year
- Normal cognitive function
- The subject himself or his legal representative can sign the informed consent form
Who cannot join
- Patients with other dystonia who did not meet the inclusion criteria
- Diagnosed with other neuropsychiatric diseases (Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.)
- Previous history of craniocerebral surgery
- Major depression or anxiety
- The presence of neurosurgical contraindications such as cerebral infarction, hydrocephalus, cerebral atrophy, and sequelae of cerebrovascular disease
- Contraindications to CT/MRI scanning (e.g. Claustrophobia)
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- women known to be pregnant or lactating, or who had a positive pregnancy test before randomization
- Presence of contraindications to general anesthesia (such as severe arrhythmia, severe anemia, abnormal liver and kidney function, etc.)
- Expected survival less than 12 months
- has participated in other interventional clinical studies that may have affected the outcome assessment
- other circumstances considered by the investigator to be inappropriate for participation in the study or likely to pose a significant risk to the patient
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Ustc
Hefei, Anhui
Chaoshi Niu, 13855186208, niuchaoshi@163.com
About this study
Official title: Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation
Craniocervical dystonia, characterized by symptoms distributed in the craniofacial and/or cervical regions, is a type of focal or segmental dystonia and is the most common form of dystonia in adults. Deep brain stimulation (DBS) is a significant therapeutic approach for medically refractory craniocervical dystonia. The commonly utilized DBS targets are the Globus Pallidus internus (GPi) and the Subthalamic Nucleus (STN). Current research indicates no significant difference in efficacy between these two targets, although there are some differences in the onset time, stimulation voltage, and complications. Studies utilizing magnetic resonance imaging (MRI) to assess brain activity differences in patients with dystonia have found that patients exhibit increased activity and enhanced plasticity across a broad range of brain regions, including the brainstem, cortex, subcortical structures, and the basal ganglia, among others. Consequently, an increasing number of studies are classifying dystonia within the spectrum of brain network disorders. This study aims to recruit patients with craniocervical dystonia who meet the inclusion criteria, randomly assigning them into two groups of 30 patients each. One group will receive stimulation targeting the STN, and the other will target the GPi. Using functional MRI, researcher will conduct a dynamic brain network analysis to explore the differences in the brain network mechanisms underlying the treatment of craniocervical dystonia patients between the STN and GPi targets.
Read the detailed description
The objectives of this study are: 1) to explore the differences of brain network mechanisms between STN and GPi targets in craniocervical dystonia; 2. To explore the effects of DBS on dysarthsia and dysphagia in patients with craniocervical dystonia and the differences in efficacy, quality of life and side effects between GPi and STN targets in the treatment of craniocervical dystonia; 3. To explore the differences in the electrophysiological signals of nuclei collected during DBS surgery and their application in programming.
- Conditions
- Dystonia
- Being tested
- deep brain stimulation
- 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 stimulationDevice
Group A was the GPi-DBS stimulation group； Group B was the STN-DBS stimulation group
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | GPi-DBS group Receives: Device: deep brain stimulation |
| Group B | Experimental | STN-DBS group Receives: Device: deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting-state functional magnetic resonance imaging data
First, all participants underwent a standardized rs-fMRI scan for data collection of resting-state BOLD signals. Secondly, data preprocessing was carried out, including head movement correction, non-brain tissue removal, temporal layer correction, spatial normalization, filtering, and removal of physiological noise. Then, the brain network was constructed based on the pre-processed data and the structural features of the brain network were identified. Finally, statistical analysis was used to compare the differences in brain network characteristics between the two groups.
Measured: Change from baseline at 1, 6，12 months and 24 months
Secondary outcomes (7)
Burke-Fahn-Marsden Scale (BFMDRS)
This scale was used to evaluate the severity of dystonia in the subjects, with a total score of 120 points, with higher scores indicating greater symptom severity
Measured: Change from baseline at 1, 6，12 months and 24 months
Toronto West Spasmodic Torticollis Rating Scale Scale(TWSTRS)
The total score ranges from 0 to 85, with higher scores indicating more severe disease symptoms
Measured: Change from baseline at 1, 6，12 months and 24 months
Craniocervical Dystonia Questionnaire
The questionnaire each entry into 0 (never) - 4 points (always), higher scores on behalf of the increasingly serious damage
Measured: Change from baseline at 1, 6，12 months and 24 months
Frenchay dysarthria scale
The scale is divided into 28, each fine items according to the severity was divided into a to e grade 5
Measured: Change from baseline at 1, 6，12 months and 24 months
Watian Drinking Experiment
The Watian Drinking Experiment was used to evaluate the swallowing function of the subjects on a 5-point scale, and the normal level was 1 (swallow water within 5 seconds). Suspicious for level 1 (more than 5 seconds will swallow water) or level 2; Exception for 3 ~ 5
Measured: Change from baseline at 1, 6，12 months and 24 months
Number of Deep Brain Stimulation programming
The number of times participants were programmed after DBS
Measured: Change from baseline at 1, 6，12 months and 24 months
Number of side effects in Deep Brain Stimulation programming
Measured: Change from baseline at 1, 6，12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Mar 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Device: Deep Brain Stimulation (DBS) of Gpi，PINS G106R Device: Deep Brain Stimulation (DBS) of STN，PINS G106R
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Beijing Pins Medical Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480188
- Sponsor's protocol ID
- 2024KY-102
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Brain Network Mechanisms Between STN and GPi Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT06480188
- Acronym / sponsor ID
- 2024KY-102
- Conditions
- Dystonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- Beijing Pins Medical Co., Ltd
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 28 Jun 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.
Craniocervical dystonia, characterized by symptoms distributed in the craniofacial and/or cervical regions, is a type of focal or segmental dystonia and is the most common form of dystonia in adults. Deep brain stimulation (DBS) is a significant therapeutic approach for medically refractory craniocervical dystonia. The commonly utilized DBS targets are the Globus Pallidus internus (GPi) and the Subthalamic Nucleus (STN). Current research indicates no significant difference in efficacy between these two targets, although there are some differences in the onset time, stimulation voltage, and complications. Studies utilizing magnetic resonance imaging (MRI) to assess brain activity differences in patients with dystonia have found that patients exhibit increased activity and enhanced plasticity across a broad range of brain regions, including the brainstem, cortex, subcortical structures, and the basal ganglia, among others. Consequently, an increasing number of studies are classifying dystonia within the spectrum of brain network disorders. This study aims to recruit patients with craniocervical dystonia who meet the inclusion criteria, randomly assigning them into two groups of 30 patients each. One group will receive stimulation targeting the STN, and the other will target the GPi. Using functional MRI, researcher will conduct a dynamic brain network analysis to explore the differences in the brain network mechanisms underlying the treatment of craniocervical dystonia patients between the STN and GPi targets.
Detailed description
The objectives of this study are: 1) to explore the differences of brain network mechanisms between STN and GPi targets in craniocervical dystonia; 2. To explore the effects of DBS on dysarthsia and dysphagia in patients with craniocervical dystonia and the differences in efficacy, quality of life and side effects between GPi and STN targets in the treatment of craniocervical dystonia; 3. To explore the differences in the electrophysiological signals of nuclei collected during DBS surgery and their application in programming.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Device: Deep Brain Stimulation (DBS) of Gpi，PINS G106R Device: Deep Brain Stimulation (DBS) of STN，PINS G106R
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: deep brain stimulationGPi-DBS group |
| Group B | Experimental | Device: deep brain stimulationSTN-DBS group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years
- Meeting the diagnostic criteria for primary craniocervical dystonia (including patients with cranial, cervical, or unilateral extremity dystonia)
- Disease duration ≥1 year
- Normal cognitive function
- The subject himself or his legal representative can sign the informed consent form
Key exclusion criteria (11 listed)
- Patients with other dystonia who did not meet the inclusion criteria
- Diagnosed with other neuropsychiatric diseases (Alzheimer's disease, amyotrophic lateral sclerosis, Parkinson's disease, etc.)
- Previous history of craniocerebral surgery
- Major depression or anxiety
- The presence of neurosurgical contraindications such as cerebral infarction, hydrocephalus, cerebral atrophy, and sequelae of cerebrovascular disease
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 stimulationGroup A was the GPi-DBS stimulation group； Group B was the STN-DBS stimulation group | Device | Group A, Group B |
Primary outcome
resting-state functional magnetic resonance imaging data
Time frame: Change from baseline at 1, 6，12 months and 24 months
First, all participants underwent a standardized rs-fMRI scan for data collection of resting-state BOLD signals. Secondly, data preprocessing was carried out, including head movement correction, non-brain tissue removal, temporal layer correction, spatial normalization, filtering, and removal of physiological noise. Then, the brain network was constructed based on the pre-processed data and the structural features of the brain network were identified. Finally, statistical analysis was used to compare the differences in brain network characteristics between the two groups.
7 secondary outcomes
Burke-Fahn-Marsden Scale (BFMDRS)
Time frame: Change from baseline at 1, 6，12 months and 24 months
Toronto West Spasmodic Torticollis Rating Scale Scale(TWSTRS)
Time frame: Change from baseline at 1, 6，12 months and 24 months
Craniocervical Dystonia Questionnaire
Time frame: Change from baseline at 1, 6，12 months and 24 months
Frenchay dysarthria scale
Time frame: Change from baseline at 1, 6，12 months and 24 months
Watian Drinking Experiment
Time frame: Change from baseline at 1, 6，12 months and 24 months
Number of Deep Brain Stimulation programming
Time frame: Change from baseline at 1, 6，12 months and 24 months
Number of side effects in Deep Brain Stimulation programming
Time frame: Change from baseline at 1, 6，12 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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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.
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 Anhui Provincial 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 5 inclusion and 11 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 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chaoshi Niu (13855186208, niuchaoshi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting-state functional magnetic resonance imaging data (time frame: Change from baseline at 1, 6，12 months and 24 months). 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 8 Jul 2024.