NCT06494956

Brief Summary

To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

June 17, 2024

Last Update Submit

July 7, 2024

Conditions

Parkinson Disease Dementia

Outcome Measures

Primary Outcomes (4)

  • Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary

    Subjects fill in diary cards

    7 months

  • Subjects fill in a diary card after device implantation

    Subjects fill in diary cards

    6 months

  • Drug dosage evaluation

    Subjects fill in diary cards

    7 months

  • Charging performance evaluation

    Subjects fill in diary cards

    6 months

Study Arms (1)

Single unit

EXPERIMENTAL

An implantable computer fills the deep nervous system and turns it on for treatment

Procedure: Implant device

Interventions

Implant devicePROCEDURE

A subcutaneous tunnel was established under general anesthesia, the electrode was connected to the stimulator, and the pulse generator was implanted in the skull.

Single unit

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2024

First Posted

July 10, 2024

Study Start

July 1, 2024

Primary Completion

October 31, 2024

Study Completion

July 31, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07