PSA Versus STN DBS for TD-PD

Parkinson Disease Clinical Trial

— PSA-STN  

Official title:

Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382858
• Other study ID #: TDPSA
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 2027

Study information

• Verified date: February 2023
• Source: Ruijin Hospital
• Contact: Dianyou Li, MD, PhD
• Phone: +0086-021-64370045
• Email: ldy11483[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.

Description:

This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Two months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 6 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• diagnosis of idiopathic Parkinson's disease

• tremor-dominant subtype in the on-medication condition

• modified Hoehn-Yahr scale of 2 to 4 in the on-medication condition

• receiving regular anti-parkinsonian drugs for more than 6 weeks

• good compliance and written informed consent provided

Exclusion Criteria:

• Atypical parkinsonism

• History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery

• Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent

• Presence of anatomical abnormalities in the target region

• Clinically significant medical history that would increase pre-/post-operative complications

• Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Deep brain stimulation
active DBS with optimal stimulating parameters

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Suzhou Sceneray Medical Co. , Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 4 months	in the off-medication condition	4 months
Primary	Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months	in the off-medication condition	6 months
Secondary	Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 4 months		4 months
Secondary	Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 6 months		6 months
Secondary	Change from baseline Timed up and go test to 4 months	in the off-medication condition	4 months
Secondary	Change from baseline Timed up and go test to 6 months	in the off-medication condition	6 months
Secondary	Change from baseline Berg balance scale to 4 months	in the off-medication condition	4 months
Secondary	Change from baseline Berg balance scale to 6 months	in the off-medication condition	6 months
Secondary	Change from baseline 39-item Parkinsons disease questionnaire to 4 months		4 months
Secondary	Change from baseline 39-item Parkinsons disease questionnaire to 6 months		6 months
Secondary	Change from baseline Levodopa equivalent daily dose to 4 months		4 months
Secondary	Change from baseline Levodopa equivalent daily dose to 6 months		6 months
Secondary	Change from baseline maximal phonatory time to 4 months		4 months
Secondary	Change from baseline maximal phonatory time to 6 months		6 months
Secondary	Change from baseline dysphonia severity index to 4 months		4 months
Secondary	Change from baseline dysphonia severity index to 6 months		6 months
Secondary	Change from baseline Mini-Mental Status Exam to 4 months		4 months
Secondary	Change from baseline Mini-Mental Status Exam to 6 months		6 months
Secondary	Change from baseline Beck depression inventory to 4 months		4 months
Secondary	Change from baseline Beck depression inventory to 6 months		6 months
Secondary	Adverse events		up to 12 months after surgery