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Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia

Primary Purpose

Cervical Dystonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GPi-DBS
STN-DBS
GPi-DBS devices
STN-DBS devices
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring globus pallidus internus, subthalamic nucleus, deep brain stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria 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; 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. Exclusion criteria 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.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GPi-DBS

STN-DBS

Arm Description

The DBS electrodes are implanted into posteroventral GPi bilaterally.

The DBS electrodes are implanted into dorsolateral STN bilaterally.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Adverse effects
Any adverse event occurring between the beginning time of the trial and the last follow-up.

Full Information

First Posted
January 10, 2023
Last Updated
July 19, 2023
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05715138
Brief Title
Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia
Official Title
A Randomized Controlled Trial Comparing PAllidal and SubThalamic Deep Brain Stimulation for Cervical Dystonia(the PASTS-CD Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
Keywords
globus pallidus internus, subthalamic nucleus, deep brain stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GPi-DBS
Arm Type
Experimental
Arm Description
The DBS electrodes are implanted into posteroventral GPi bilaterally.
Arm Title
STN-DBS
Arm Type
Experimental
Arm Description
The DBS electrodes are implanted into dorsolateral STN bilaterally.
Intervention Type
Procedure
Intervention Name(s)
GPi-DBS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
STN-DBS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
GPi-DBS devices
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
STN-DBS devices
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 3 months
Description
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.
Time Frame
Three months postoperatively.
Title
Change from baseline Tsui scale at 3 months
Description
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.
Time Frame
Three months postoperatively.
Title
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 6 months
Description
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.
Time Frame
Six months postoperatively.
Title
Change from baseline Tsui scale at 6 months
Description
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.
Time Frame
Six months postoperatively.
Title
Change from baseline Toronto Western Spasmodic Torticollis Rating Scale - Severity subscale (TWSTRS-Severity) at 1 year
Description
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.
Time Frame
One year postoperatively.
Title
Change from baseline Tsui scale at 1 year
Description
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.
Time Frame
One year postoperatively.
Secondary Outcome Measure Information:
Title
Change of Toronto Western Spasmodic Torticollis Rating Scale - Disability subscale (TWSTRS-Disability)
Description
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.
Time Frame
Three months postoperatively, six months postoperatively, and one year postoperatively.
Title
Change of Toronto Western Spasmodic Torticollis Rating Scale - Pain subscale (TWSTRS-Pain)
Description
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.
Time Frame
Three months postoperatively, six months postoperatively, and one year postoperatively.
Title
Change of 36-item Short Form General Health Survey (SF-36)
Description
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.
Time Frame
Six months postoperatively, and one year postoperatively.
Title
Change of Hamilton Anxiety Scale (HAMA)
Description
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.
Time Frame
Six months postoperatively, and one year postoperatively.
Title
Change of 24-item Hamilton Depression Scale (HAMD)
Description
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.
Time Frame
Six months postoperatively, and one year postoperatively.
Title
Change of Mini-mental State Examination (MMSE)
Description
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.
Time Frame
Six months postoperatively, and one year postoperatively.
Title
Change of Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Six months postoperatively, and one year postoperatively.
Title
Total electrical energy delivered (TEED)
Description
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.
Time Frame
One year postoperatively.
Title
Adverse effects
Description
Any adverse event occurring between the beginning time of the trial and the last follow-up.
Time Frame
Up to 1 year postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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; 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. Exclusion criteria 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiqi Mao, PhD
Phone
8618910155994
Email
markmaoqi@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Liu, MD
Phone
8618561812781
Email
liubinsdu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiqi Mao, PhD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bin Liu, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqi Mao, Ph.D
Phone
8618910155994
Email
markmaoqi@126.com
First Name & Middle Initial & Last Name & Degree
Bin Liu, MD
Phone
8618561812781
Email
liubinsdu@163.com
First Name & Middle Initial & Last Name & Degree
Zhiqi Mao, Ph.D
First Name & Middle Initial & Last Name & Degree
Bin Liu, MD
First Name & Middle Initial & Last Name & Degree
Rui Hui, MD
First Name & Middle Initial & Last Name & Degree
Jie Meng, MD
First Name & Middle Initial & Last Name & Degree
Di Liu, MD
First Name & Middle Initial & Last Name & Degree
Shufeng Liang, MD
First Name & Middle Initial & Last Name & Degree
Zhebin Feng, MD
First Name & Middle Initial & Last Name & Degree
Jun Hong, MD

12. IPD Sharing Statement

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Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia

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