MedTrace Logo

Simpler and Safer Deep Brain Stimulation for Parkinson's Disease

NCT03837314 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-10-30

No results posted yet for this study

Summary

The aim is to improve availability and acceptability of deep brain stimulation (DBS) for the treatment of Parkinson by shortening and simplifying the implantation procedure, thereby reducing time in surgery, complexity, post-surgery complications and cost, and increasing patient satisfaction.

To facilitate the shortening and simplifying of the implantation procedure, a miniaturised skull-mounted DBS device (Picostim) has been developed which is optimised to generate waveforms needed for stimulation of the subthalamic nucleus (STN) and STN region, employing a unique method of controlling stimulation current. The planned study is a single centre, open label, non-randomised design with the primary objective of showing similarity in control of motor symptoms for the Picostim device compared with previously published data for existing DBS devices.

Conditions

Interventions

DEVICE

Bioinduction "Picostim" Deep Brain Stimulation system

Neurostimulation of the subthalamic nucleus region.

Sponsors & Collaborators

  • Bioinduction

    collaborator INDUSTRY

  • North Bristol NHS Trust

    lead OTHER

Principal Investigators

  • Alan Whone, PhD · North Bristol NHS Trust

  • Nik Patel, MD · North Bristol NHS Trust

  • Steve Gill, MD · North Bristol NHS Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2025-06-01
Completion
2026-01-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837314 on ClinicalTrials.gov