Clinical trial NCT06012461: Closed-loop DBS in Parkinson's Disease
Official title: Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Deep Brain Stimulation
Closed-loop DBS
Lead sponsor: Tsinghua University
Sponsor class: OTHER
Collaborators: name: National Engineering Research Center of Neuromodulation, Tsinghua University
name: Beijing Tiantan Hospital
name: Peking Union Medical College Hospital
name: Beijing Pins Medical Co., Ltd
First posted: 2023-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Good response to levodopa combination therapy.
3. Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
4. Intolerable adverse reactions to medication affecting its efficacy.
5. Presence of uncontrollable tremors despite medication.

Exclusion Criteria:

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

Primary outcomes:
measure: Movement disorders evaluation
timeFrame: 1-3 days
measure: Sleep Structure Evaluation
timeFrame: 1-3 nights
measure: Diary Outcomes in Parkinson's Disease
timeFrame: 1-3days
Secondary outcomes:
measure: Safety (Stimulation-related AEs) and Subjective Satisfactory
timeFrame: 1-3days
measure: Total Electrical Energy Delivered to patients
timeFrame: 1-3days
Other outcomes:
measure: Neurophysiological changes of STN-LFP in daytime and sleep
timeFrame: at 3,6,9,12,15 months compared to baseline
measure: Functional connectivity changes during long-term DBS modulation
timeFrame: at 3,6,9,12,15 months compared to baseline
Locations:
city: Beijing
country: China
facility: National Engineering Research Center of Neuromodulation
state: Beijing
Study officials:
References: