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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05382858
Other study ID # TDPSA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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