Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia

NCT05715138 | Not Yet Recruiting

• 1 other identifier: ChinaPLAGH_LB
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dystonia

Keywords

globus pallidus internus; subthalamic nucleus; deep brain stimulation

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  One year postoperatively.

Secondary Outcomes (9)

• Change of Toronto Western Spasmodic Torticollis Rating Scale - Disability subscale (TWSTRS-Disability)

  Three months postoperatively, six months postoperatively, and one year postoperatively.

• Change of Toronto Western Spasmodic Torticollis Rating Scale - Pain subscale (TWSTRS-Pain)

  Three months postoperatively, six months postoperatively, and one year postoperatively.

• Change of 36-item Short Form General Health Survey (SF-36)

  Six months postoperatively, and one year postoperatively.

• Change of Hamilton Anxiety Scale (HAMA)

  Six months postoperatively, and one year postoperatively.

• Change of 24-item Hamilton Depression Scale (HAMD)

  Six months postoperatively, and one year postoperatively.

Study Arms (2)

GPi-DBS

EXPERIMENTAL

The DBS electrodes are implanted into posteroventral GPi bilaterally.

Procedure: GPi-DBS; Device: GPi-DBS devices

STN-DBS

EXPERIMENTAL

The DBS electrodes are implanted into dorsolateral STN bilaterally.

Procedure: STN-DBS; Device: STN-DBS devices

Interventions

GPi-DBS PROCEDURE

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.

GPi-DBS

STN-DBS PROCEDURE

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.

STN-DBS

GPi-DBS devices DEVICE

1. 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).

GPi-DBS

STN-DBS devices DEVICE

1. 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).

STN-DBS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

Location

Related Publications (1)

• 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.

  PMID: 37832982 DERIVED

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhiqi Mao, PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Bin Liu, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiqi Mao, PhD

CONTACT

8618910155994; markmaoqi@126.com

Bin Liu, MD

CONTACT

8618561812781; liubinsdu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 6, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

CN (1)