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NCT03837314: SPARKS

Simpler and Safer Deep Brain Stimulation for Parkinson's Disease

Status unknown NA Last updated 30 October 2023
What this trial tests

NA trial testing Bioinduction "Picostim" Deep Brain Stimulation system in Parkinson's Disease in 25 participants. Status unknown.

Timeline
28 October 2020
Primary endpoint
1 June 2025
1 January 2026

Quick facts

Lead sponsorNorth Bristol NHS Trust
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date28 October 2020
Primary completion1 June 2025
Estimated completion1 January 2026
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

North Bristol NHS Trust — full company profile →

Who can join

21 and older, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Implantable Pulse Generators for Deep Brain Stimulation: Challenges, Complications, and Strategies for Practicality and Longevity.
    Sarica C, Iorio-Morin C, Aguirre-Padilla DH, Najjar A, et al · · 2021 · cited 50× · PMID 34512295 · DOI 10.3389/fnhum.2021.708481
  2. DyNeuMo Mk-1: Design and pilot validation of an investigational motion-adaptive neurostimulator with integrated chronotherapy.
    Zamora M, Toth R, Morgante F, Ottaway J, et al · · 2022 · cited 29× · PMID 35016994 · DOI 10.1016/j.expneurol.2022.113977
  3. Deep brain-machine interfaces: sensing and modulating the human deep brain.
    Sui Y, Yu H, Zhang C, Chen Y, et al · · 2022 · cited 13× · PMID 36644311 · DOI 10.1093/nsr/nwac212
  4. A clinical grade neurostimulation implant for hierarchical control of physiological activity
    Benjaber M, Zamora M, Toth R, Fleming JE, et al · · 2025 · DOI 10.1101/2025.10.21.683630

Verify or expand the search:

Other recruiting trials for Parkinson's Disease

Currently open trials in the same condition.

Other North Bristol NHS Trust trials

Trials by the same sponsor.

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Data sources for this page

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