Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease

NCT05997667 | Unknown

• 1 other identifier: LPDBS-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease.

Conditions

Parkinson Disease

Keywords

Rechargeable implantable deep brain stimulation (DBS) system; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med off" state relative to baseline

  MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.

  3 months after surgery

Secondary Outcomes (10)

• Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med on" state relative to baseline

  3 months after surgery

• Change in motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅱ relative to baseline

  3 and 6 months after surgery

• Change in non-motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅰ relative to baseline

  3 and 6 months after surgery

• Change in motor complications score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅳ relative to baseline

  3 and 6 months after surgery

• Change in "ON" time and "OFF" time relative to the baseline

  3 and 6 months after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

Subjects in this arm will receive stimulation of DBS system within 1 month after surgery.

Device: Rechargeable implantable deep brain stimulation system

control group

OTHER

Subjects in this arm will receive stimulation of DBS system at 3 months after surgery.

Device: Rechargeable implantable deep brain stimulation system

Interventions

Rechargeable implantable deep brain stimulation system DEVICE

The DBS system will be implanted in subjects in both study arms. Subjects in experimental group will receive stimulation of DBS system within 1 month after surgery.

experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male or female;.
• Primary PD (according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria for primary PD or Chinese diagnostic criteria for primary PD), with a duration of PD ≥ 4 years, and the improvement rate after an acute levodopa challenge test ≥ 30%; or primary PD, mainly characterized by tremor, the improvement of tremor by standardized drug treatment is not satisfactory and tremor is severe, which affects the patients' quality of life, after evaluation, duration can be relaxed to 3 years, the improvement rate of acute levodopa challenge test can be\<30%.
• The use of levodopa once had good effects, but currently cannot satisfactorily control symptoms (significant decrease in efficacy or occurrence of fluctuations in motor function or motor dysfunction), which affects quality of life.
• Good compliance, patients and their families have the willingness to participate in the clinical trial of "bilateral implantation surgery of nervous stimulation system", voluntarily participate in this trial and sign informed consent form, patients can follow up regularly, and can accurately complete of assessment items, or the family members, guardians, or caregivers may assist the patients.

You may not qualify if:

• Severe cognitive impairment (MMSE score: illiterate\<17, elementary school\<20, junior high school or above\<24), poor compliance due to dementia, and/or inability to sign informed consent form
• Patients with a history of severe mental illness and a Hamilton Depression Scale (HAMD) score\>24
• Seizure history in the last 1 year
• Patients with severe heart, liver and kidney diseases, severe hypertension and severe orthostatic hypotension that affect their health status.
• Patients with severe diabetes or serious cardiovascular and cerebrovascular diseases that affect their health status
• Confirmed malignant tumor
• Patients with surgical contraindications (e.g., the presence of active implants (whether turned on or not), or the presence of non-active implants that may affect the deep brain stimulation system, stereotactic nucleus lesioning, etc.), or other surgical procedures within six months that the researchers believe have an impact on this trial, or other neurosurgery contraindications
• Patients who have suffered a previous cranial neurological injury
• Women who are pregnant or preparing for pregnancy
• Patients with severe alcohol dependence and drug abuse
• Patients who received electric shock therapy within 30 days before surgery
• Patients who are abnormally sensitive to temperature or who are allergic to heat
• Subjects who are currently participating in other clinical trials or have participated in other clinical studies that have not reached the primary endpoint within three months.
• Patients who are not suitable to participate in this clinical study in the opinion of the investigator.

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (7)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

NOT YET RECRUITING

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510260, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

NOT YET RECRUITING

The Second Affiliated Hospital of Air Force Medical University

Xi'an, Shaanxi, 524001, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Ting Zhang

CONTACT

+86-010-80120666; ting_zhang@lepumedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 18, 2023
• Study Start: July 20, 2023
• Primary Completion: January 20, 2025
• Study Completion: July 20, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

CN (7)