NCT03837314

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 16, 2015

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 28, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 30, 2023

Status Verified

May 1, 2023

Enrollment Period

4.6 years

First QC Date

April 16, 2015

Last Update Submit

October 27, 2023

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseDeep Brain StimulationNeuromodulation

Outcome Measures

Primary Outcomes (2)

  • Change in motor function.

    Change in the Unified Parkinson's Disease Rating Scale (UPDRS) III score at 26 weeks post implantation with stimulation on without medication compared with baseline assessment (without medication). Standard range is from 0 to 108, lower score is better than higher score

    26 weeks

  • Collection and recording of adverse events

    Rate and type of adverse events including serious adverse events, procedure-related, device-related, stimulation-related, and other adverse events

    26 weeks

Secondary Outcomes (14)

  • Surgical time to complete procedure

    12, 26 and 52 weeks intra-operative post device implantation.

  • Post-operation complications: % of patients with infections and pain at the implantation site

    12 weeks

  • Tolerability and satisfaction with the head mounted device on a 1-10 range Patient satisfaction questionnaire

    12, 26 and 52 weeks post device implantation.

  • Motor functions assessed through recording of motor fluctuation diary

    12, 26 and 52 weeks post device implantation.

  • Mentation, Behaviour and Mood assessed through standard UPDRS Test (see description)

    12, 26 and 52 weeks post device implantation.

  • +9 more secondary outcomes

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Deep Brain stimulation using a novel device. Bioinduction "Picostim" Deep Brain Stimulation system

Device: Bioinduction "Picostim" Deep Brain Stimulation system

Interventions

Bioinduction "Picostim" Deep Brain Stimulation systemDEVICE

Neurostimulation of the subthalamic nucleus region.

Deep Brain Stimulation

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who report motor symptoms of Parkinson for at least 4 years;
  • Patients eligible for DBS Surgery;
  • Receiving stable medical therapy for 30 days or longer before screening assessments - as reported by the patient;
  • Males and females aged 21 years or older;
  • Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary);
  • Understands the study requirements and the treatment procedures and is able to provide written informed consent;
  • Females of child-bearing potential must have a negative pregnancy test at study entry and report using an effective method of contraception;

You may not qualify if:

  • Atypical Parkinsonian (Parkinson-plus) syndromes;
  • Any prior movement disorder treatments that involved intracranial surgery or device implantation;
  • Presence of or planned implant of any other active implanted device;
  • Surgical contraindications (such as issues preventing safe anaesthesia);
  • Contraindications for MRI scanning (such as presence of metal in the body which means scanning may be harmful);
  • Active alcohol or drug abuse;
  • Dementia or any neuropsychological condition or finding that would contraindicate DBS surgery. Mattis DRS-2 AEMSS of 6 or less;
  • Previous brain surgery likely to interfere with DBS implant;
  • Frequent falls when on adequate medication therapy in an "on" state, in the opinion of the PI/delegated clinician;
  • A past or current psychiatric disturbance that in the opinion of the PI contraindicates DBS surgery;
  • Use of anticoagulant medications that cannot be discontinued during perioperative period;
  • Clinically problematic dopamine dysregulation syndrome in the opinion of the PI;
  • Significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with expected survival of less than 5 years;
  • Participation in another trial concurrently or within 30 days preceding enrolment, that is deemed to interfere with this trial;
  • Females who are pregnant, considering becoming pregnant during the study period, or who are breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Brain Centre, Elgar House, Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Alan Whone, PhD

    North Bristol NHS Trust

    PRINCIPAL INVESTIGATOR

  • Nik Patel, MD

    North Bristol NHS Trust

    PRINCIPAL INVESTIGATOR

  • Steve Gill, MD

    North Bristol NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 16, 2015

First Posted

February 12, 2019

Study Start

October 28, 2020

Primary Completion

June 1, 2025

Study Completion

January 1, 2026

Last Updated

October 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)