Closed-loop DBS in Parkinson's Disease

NCT06012461 | Unknown

• 1 other identifier: CDBS_PD_2023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Deep Brain Stimulation; Closed-loop DBS

Outcome Measures

Primary Outcomes (3)

• Movement disorders evaluation

  Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition

  1-3 days

• Sleep Structure Evaluation

  Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition

  1-3 nights

• Diary Outcomes in Parkinson's Disease

  Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition

  1-3days

Secondary Outcomes (2)

• Safety (Stimulation-related AEs) and Subjective Satisfactory

  1-3days

• Total Electrical Energy Delivered to patients

  1-3days

Other Outcomes (2)

• Neurophysiological changes of STN-LFP in daytime and sleep

  at 3,6,9,12,15 months compared to baseline

• Functional connectivity changes during long-term DBS modulation

  at 3,6,9,12,15 months compared to baseline

Study Arms (1)

Bilateral STN DBS Modulation

EXPERIMENTAL

Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy.

Other: Closed-loop DBS stimulation for 24 hours; Other: Open-loop DBS stimulation for 24 hours; Other: Closed-loop DBS stimulation for 72 hours; Other: Open-loop DBS stimulation for 72 hours

Interventions

Closed-loop DBS stimulation for 24 hours OTHER

Continuous closed-loop modulation for 24 hours

Bilateral STN DBS Modulation

Open-loop DBS stimulation for 24 hours OTHER

Continuous open-loop modulation for 24 hours

Bilateral STN DBS Modulation

Closed-loop DBS stimulation for 72 hours OTHER

Continuous closed-loop modulation for 72 hours

Bilateral STN DBS Modulation

Open-loop DBS stimulation for 72 hours OTHER

Continuous open-loop modulation for 72 hours

Bilateral STN DBS Modulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in 2015.
• Good response to levodopa combination therapy.
• Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
• Intolerable adverse reactions to medication affecting its efficacy.
• Presence of uncontrollable tremors despite medication.

You may not qualify if:

• Patients who have undergone pallidotomy or other brain surgeries.
• Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
• Patients with concurrent central nervous system and peripheral nervous system diseases.
• Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
• Patients with severe psychiatric disorders.
• Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.

Sponsors & Collaborators

• Tsinghua University: lead
• National Engineering Research Center of Neuromodulation, Tsinghua University: collaborator
• Beijing Tiantan Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Beijing Pins Medical Co., Ltd: collaborator

Study Sites (1)

National Engineering Research Center of Neuromodulation

Beijing, Beijing Municipality, 100084, China

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

Weizhi Pan, B.S.

CONTACT

+86-010-62796172; neln@mail.tsinghua.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: August 25, 2023
• Study Start: June 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)