Cervical DystoniaNCT05715138
Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia
A study testing GPi-DBS, STN-DBS and GPi-DBS devices in people with Cervical Dystonia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Cervical dystonia (CD), also known as spasmodic torticollis, is a type of focal dystonia, mainly manifesting as involuntary head turning or tilting, or holding a twisted posture. Although it can be alleviated by injection of botulinum toxin, the effect is temporary so that patients require multiple injections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- GPi-DBS, STN-DBS and GPi-DBS devices
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Nov 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as idiopathic or hereditary isolated CD;
- Severe functional impairment;
- Oral medication and injection of botulinum toxin become ineffective (> 3 months since last injection), or refuse to adopt botulinum toxin injection;
- No secondary causes of CD;
- Age 18-80 years old;
- Normal neurological examination except for dystonia;
Show all 9Show fewer
- Normal brain MRI;
- The subject or their family members can fully understand the trial and sign the informed consent;
- Good compliance and willingness to receive regular follow-ups.
Who cannot join
- Diagnosed as secondary CD;
- CD with obvious trunk/limb involvement, or Meige syndrome;
- History of severe mental disorders, dementia, or epilepsy;
- Previous dystonia surgery (pallidotomy, thalamotomy, DBS, etc);
- Accompanied by other neurological diseases (Parkinson's disease, essential tremor, multiple sclerosis, stroke, etc);
- The patient has or needs other implantable devices (cardiac pacemakers, defibrillators, cochlear implants, spinal cord stimulators, etc);
- Pregnant women or women who are waiting to become pregnant during the trial;
- Poor health condition.
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
Chinese PLA General Hospital
Beijing, 100853
Zhiqi Mao, Ph.D, 8618910155994, markmaoqi@126.com
Bin Liu, MD, 8618561812781, liubinsdu@163.com
About this study
Official title: A Randomized Controlled Trial Comparing PAllidal and SubThalamic Deep Brain Stimulation for Cervical Dystonia（the PASTS-CD Study）
Cervical dystonia (CD), also known as spasmodic torticollis, is a type of focal dystonia, mainly manifesting as involuntary head turning or tilting, or holding a twisted posture. Although it can be alleviated by injection of botulinum toxin, the effect is temporary so that patients require multiple injections. Deep Brain Stimulation (DBS) targeting on globus pallidus internus (GPi) or subthalamic nucleus (STN) has been proved to be a safe and effective strategy for primary cervical dystonia, even for those medically refractory cases. However, the question of which target is better has not been clarified.
Therefore, the invstigators design this randomized and controlled trial, aiming to compare the differences between GPi-DBS and STN-DBS for cervical dystonia in the improvement of symptoms , quality of life, mental status, cognitive status, as well as in stimulation parameters and adverse effects. The invstigators hypothesize that STN-DBS will outperform GPi-DBS at short-term follow-up, while the superiority will disappear and the efficacy of the two group will become similar at long-term follow-up.
Read the detailed description
CD limits the neck activity by involving one or a group of neck muscles and is often accompanied by pain and psychological disorders, seriously affecting the quality of life. GPi and STN are two dominant targets for DBS, either of which has been widely used in the treatment of CD with remarkable efficacy (about 50%-90% symptomatic improvement rate). However, there has been no prospective studies to directly compare the DBS efficacy of these two targets.
The invstigators plan to design a multicenter, prospective, randomized, parallel-controlled equivalent clinical trial, aiming to compare GPi-DBS with STN-DBS for drug-resistant CD in the following aspects: (1) improvement rate of dystonic symptoms, (2) improvement rate of life quality, mental and cognitive status, (3) stimulation parameters, (4) adverse effects.
According to the inclusion and exclusion criteria, a total of 98 idiopathic or hereditary isolated CD patients will be enrolled, each of whom will be randomly divided into GPi-DBS group or STN-DBS group in a 1:1 ratio by central randomization. Informed consent forms are signed and information at baseline is collected. A standardized video will be recorded to assess the severity of the disease. The DBS electrodes will be implanted into posteroventral GPi (GPi-DBS group) or dorsolateral STN (STN-DBS group) respectively. The other operation procedures and subsequent follow-up plan are the same. The DBS device will be switched on in four weeks postoperatively and the optimal stimulation parameters will be used. The invstigators will record standardized videos and/or complete a series of clinical scales (see outcome measures) for all patients at baseline, four weeks postoperatively (after activation of DBS device), three months postoperatively, six months postoperatively, and one year postoperatively. Meanwhile, the stimulation parameters and adverse effects will also be documented. Finally, two professional raters will assess the severity of CD (reflected by Toronto Western Spasmodic Torticollis Rating Scale and Tsui scale) at different timepoints according to those standardized videos in a blind manner.
Intention-to-treatment analysis and per protocol analysis are both conducted by a professional data analyst.
- Conditions
- Cervical Dystonia
- Being tested
- GPi-DBS, STN-DBS, GPi-DBS devices, STN-DBS devices
- Keywords
- globus pallidus internus, subthalamic nucleus, deep brain stimulation
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPi-DBSProcedure or surgery
An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into the posteroventral part of bilateral GPi nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.
STN-DBSProcedure or surgery
An elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 0.5mm) will be inserted into the dorsolateral part of bilateral STN nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously.
GPi-DBS devicesDevice
- DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China);
- Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China);
- Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).
STN-DBS devicesDevice
- DBS electrode: 3389 (Medtronic, Minneapolis, MN, USA) or L301 (PINS Medical, Beijing, China) or 1200 (SceneRay, Suzhou, China);
- Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China);
- Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).
| Study group | Role | What they receive |
|---|---|---|
| GPi-DBS | Experimental | The DBS electrodes are implanted into posteroventral GPi bilaterally. Receives: Procedure: GPi-DBS; Device: GPi-DBS devices |
| STN-DBS | Experimental | The DBS electrodes are implanted into dorsolateral STN bilaterally. Receives: Procedure: STN-DBS; Device: STN-DBS devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 3 months
TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.
Measured: Three months postoperatively.
Change from baseline Tsui scale at 3 months
Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.
Measured: Three months postoperatively.
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 6 months
TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.
Measured: Six months postoperatively.
Change from baseline Tsui scale at 6 months
Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.
Measured: Six months postoperatively.
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 1 year
TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.
Measured: One year postoperatively.
Change from baseline Tsui scale at 1 year
Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.
Measured: One year postoperatively.
Secondary outcomes (9)
Change of Toronto Western Spasmodic Torticollis Rating Scale - Disability subscale (TWSTRS-Disability)
TWSTRS-Disability subscale can reflect the disability of the dystonia. The total score of TWSTRS-Disability subscale is 30 points. Higher scores indicate more compromised living ability.
Measured: Three months postoperatively, six months postoperatively, and one year postoperatively.
Change of Toronto Western Spasmodic Torticollis Rating Scale - Pain subscale (TWSTRS-Pain)
TWSTRS-Pain subscale can reflect the level of the neck pain. The total score of TWSTRS-Pain subscale is 20 points. Higher scores indicate more severe neck pain.
Measured: Three months postoperatively, six months postoperatively, and one year postoperatively.
Change of 36-item Short Form General Health Survey (SF-36)
The SF-36 scale is a comprehensive index that reflects the health status of individuals.This scale has 8 dimensions to evaluate health-related quality of life, namely, physical function (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH). Higher score indicates better health status.
Measured: Six months postoperatively, and one year postoperatively.
Change of Hamilton Anxiety Scale (HAMA)
HAMA score can better reflect the severity of anxiety. It is composed of two parts, namely, physical anxiety (item 7-13) and mental anxiety (item 1-6, 14). Total score ≥ 29 points: severe anxiety; Total score ≥21 points: there must be significant anxiety; Total score ≥14 points: there must be anxiety; Total score ≥ 7 points: you may have anxiety; Total score < 7 points: there are no symptoms of anxiety.
Measured: Six months postoperatively, and one year postoperatively.
Change of 24-item Hamilton Depression Scale (HAMD)
HAMD score can better reflect the severity of depression. Total score < 7 points: normal; Total score 7-17 points: possible depression; Total score 17-24 points: definitely depression; Total score > 24 points: severe depression.
Measured: Six months postoperatively, and one year postoperatively.
Change of Mini-mental State Examination (MMSE)
MMSE is a screening scale for Alzheimer's disease. It consists of 20 questions with 30 items (30 points), including five aspects: orientation, memory, attention and calculation, recall, language. Total score > 27 points: normal. Total score 21-27 points: mild cognitive impairment; Total score 10-20 points: moderate cognitive impairment; Total score < 9 points: severe cognitive impairment.
Measured: Six months postoperatively, and one year postoperatively.
Change of Montreal Cognitive Assessment (MoCA)
MoCA is an assessment tool for mild cognitive impairment. The cognitive domains include attention and concentration, executive function, memory, language, visuospatial skills, abstract thinking, calculation and orientation. The total score is 30 points. A score of ≥26 points is considered normal.
Measured: Six months postoperatively, and one year postoperatively.
Total electrical energy delivered (TEED)
The formula of TEED is as follows: TEED = Voltage*2*Pulse Width*Frequency/Impedance. The higher the TEED, the shorter the battery life of stimulator.
Measured: One year postoperatively.
Adverse effects
Any adverse event occurring between the beginning time of the trial and the last follow-up.
Measured: Up to 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Nov 2026 (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 Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqi Mao, Chinese PLA General Hospital
- Investigators
- Zhiqi Mao, PhD, Principal investigator, Chinese PLA General HospitalBin Liu, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715138
- Sponsor's protocol ID
- ChinaPLAGH_LB
- Status last verified
- Jul 2023
- First submitted
- 10 Jan 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu B, Xu J, Yang H, Yu X, Mao Z. PAllidal versus SubThalamic deep brain Stimulation for Cervical Dystonia (PASTS-CD): study protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Oct 13;13(10):e073425. doi: 10.1136/bmjopen-2023-073425.
PubMed 37832982
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing PAllidal and SubThalamic Deep Brain Stimulation for Cervical Dystonia（the PASTS-CD Study）
- ClinicalTrials.gov ID
- NCT05715138
- Acronym / sponsor ID
- ChinaPLAGH_LB
- Conditions
- Cervical Dystonia
- Keywords
- globus pallidus internus, subthalamic nucleus, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Feb 2023 (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.
Cervical dystonia (CD), also known as spasmodic torticollis, is a type of focal dystonia, mainly manifesting as involuntary head turning or tilting, or holding a twisted posture. Although it can be alleviated by injection of botulinum toxin, the effect is temporary so that patients require multiple injections. Deep Brain Stimulation (DBS) targeting on globus pallidus internus (GPi) or subthalamic nucleus (STN) has been proved to be a safe and effective strategy for primary cervical dystonia, even for those medically refractory cases. However, the question of which target is better has not been clarified.
Therefore, the invstigators design this randomized and controlled trial, aiming to compare the differences between GPi-DBS and STN-DBS for cervical dystonia in the improvement of symptoms , quality of life, mental status, cognitive status, as well as in stimulation parameters and adverse effects. The invstigators hypothesize that STN-DBS will outperform GPi-DBS at short-term follow-up, while the superiority will disappear and the efficacy of the two group will become similar at long-term follow-up.
Detailed description
CD limits the neck activity by involving one or a group of neck muscles and is often accompanied by pain and psychological disorders, seriously affecting the quality of life. GPi and STN are two dominant targets for DBS, either of which has been widely used in the treatment of CD with remarkable efficacy (about 50%-90% symptomatic improvement rate). However, there has been no prospective studies to directly compare the DBS efficacy of these two targets.
The invstigators plan to design a multicenter, prospective, randomized, parallel-controlled equivalent clinical trial, aiming to compare GPi-DBS with STN-DBS for drug-resistant CD in the following aspects: (1) improvement rate of dystonic symptoms, (2) improvement rate of life quality, mental and cognitive status, (3) stimulation parameters, (4) adverse effects.
According to the inclusion and exclusion criteria, a total of 98 idiopathic or hereditary isolated CD patients will be enrolled, each of whom will be randomly divided into GPi-DBS group or STN-DBS group in a 1:1 ratio by central randomization. Informed consent forms are signed and information at baseline is collected. A standardized video will be recorded to assess the severity of the disease. The DBS electrodes will be implanted into posteroventral GPi (GPi-DBS group) or dorsolateral STN (STN-DBS group) respectively. The other operation procedures and subsequent follow-up plan are the same. The DBS device will be switched on in four weeks postoperatively and the optimal stimulation parameters will be used. The invstigators will record standardized videos and/or complete a series of clinical scales (see outcome measures) for all patients at baseline, four weeks postoperatively (after activation of DBS device), three months postoperatively, six months postoperatively, and one year postoperatively. Meanwhile, the stimulation parameters and adverse effects will also be documented. Finally, two professional raters will assess the severity of CD (reflected by Toronto Western Spasmodic Torticollis Rating Scale and Tsui scale) at different timepoints according to those standardized videos in a blind manner.
Intention-to-treatment analysis and per protocol analysis are both conducted by a professional data analyst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPi-DBS | Experimental | Procedure: GPi-DBS, Device: GPi-DBS devicesThe DBS electrodes are implanted into posteroventral GPi bilaterally. |
| STN-DBS | Experimental | Procedure: STN-DBS, Device: STN-DBS devicesThe DBS electrodes are implanted into dorsolateral STN bilaterally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed as idiopathic or hereditary isolated CD;
- Severe functional impairment;
- Oral medication and injection of botulinum toxin become ineffective (> 3 months since last injection), or refuse to adopt botulinum toxin injection;
- No secondary causes of CD;
- Age 18-80 years old;
Key exclusion criteria (8 listed)
- Diagnosed as secondary CD;
- CD with obvious trunk/limb involvement, or Meige syndrome;
- History of severe mental disorders, dementia, or epilepsy;
- Previous dystonia surgery (pallidotomy, thalamotomy, DBS, etc);
- Accompanied by other neurological diseases (Parkinson's disease, essential tremor, multiple sclerosis, stroke, etc);
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 |
|---|---|---|
| GPi-DBSAn elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 1.5mm) will be inserted into the posteroventral part of bilateral GPi nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously. | Procedure or surgery | GPi-DBS |
| STN-DBSAn elaborate target/trajectory planning and a precise image fusion of MRI and stereotactic CT scanning are performed before surgery. After microelectrode recording, two sets of quadripolar DBS leads (contact interval is 0.5mm) will be inserted into the dorsolateral part of bilateral STN nuclei separately. Subsequently, an implantable pulse generator will be connected via extension wires and implanted at the left/right subclavicular area subcutaneously. | Procedure or surgery | STN-DBS |
| GPi-DBS devices1. DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China); 2. Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); 3. Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China). | Device | GPi-DBS |
| STN-DBS devices1. DBS electrode: 3389 (Medtronic, Minneapolis, MN, USA) or L301 (PINS Medical, Beijing, China) or 1200 (SceneRay, Suzhou, China); 2. Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); 3. Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China). | Device | STN-DBS |
Primary outcome
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 3 months
Time frame: Three months postoperatively.
TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.
Change from baseline Tsui scale at 3 months
Time frame: Three months postoperatively.
Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 6 months
Time frame: Six months postoperatively.
TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.
Change from baseline Tsui scale at 6 months
Time frame: Six months postoperatively.
Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 1 year
Time frame: One year postoperatively.
TWSTRS-Severity subscale can reflect the severity of the dystonia. The total score of TWSTRS-Severity subscale is 35 points. Higher scores indicate more severe symptoms.
Change from baseline Tsui scale at 1 year
Time frame: One year postoperatively.
Tsui scale can better reflect the severity of spasmodic torticollis. It consists of four parts, and the total score was calculated by A*B+C+D. The maximum score was 25 points. After treatment, a 0-10% decrease is considered ineffective, a 11%-50% decrease is considered as partial remission, a 51%-80% decrease is considered as obvious remission, and a 81%-100% decrease is considered as complete remission.
9 secondary outcomes
Change of Toronto Western Spasmodic Torticollis Rating Scale - Disability subscale (TWSTRS-Disability)
Time frame: Three months postoperatively, six months postoperatively, and one year postoperatively.
Change of Toronto Western Spasmodic Torticollis Rating Scale - Pain subscale (TWSTRS-Pain)
Time frame: Three months postoperatively, six months postoperatively, and one year postoperatively.
Change of 36-item Short Form General Health Survey (SF-36)
Time frame: Six months postoperatively, and one year postoperatively.
Change of Hamilton Anxiety Scale (HAMA)
Time frame: Six months postoperatively, and one year postoperatively.
Change of 24-item Hamilton Depression Scale (HAMD)
Time frame: Six months postoperatively, and one year postoperatively.
Change of Mini-mental State Examination (MMSE)
Time frame: Six months postoperatively, and one year postoperatively.
Change of Montreal Cognitive Assessment (MoCA)
Time frame: Six months postoperatively, and one year postoperatively.
Total electrical energy delivered (TEED)
Time frame: One year postoperatively.
Adverse effects
Time frame: Up to 1 year postoperatively.
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 21 Jul 2023.
- Derived from this study: PubMed 37832982Liu B, Xu J, Yang H, Yu X, Mao Z. PAllidal versus SubThalamic deep brain Stimulation for Cervical Dystonia (PASTS-CD): study protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Oct 13;13(10):e073425. doi: 10.1136/bmjopen-2023-073425.
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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.
Zhiqi Mao, PhD principal investigator
Chinese PLA General Hospital
Bin Liu, MD principal investigator
Chinese PLA General 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 GPi-DBS, STN-DBS and GPi-DBS devices in people with Cervical Dystonia, run by Chinese PLA General 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 8 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 21 Jul 2023. 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 Zhiqi Mao, PhD (8618910155994, markmaoqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 3 months (time frame: Three months postoperatively.). The study lists 6 primary outcomes in all. 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 NCT05715138, 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 21 Jul 2023.