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Brain Tissue Imprint

NCT03929406 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-26

No results posted yet for this study

Summary

This exploratory study aims to validate the collection and analysis of brain tissue imprints during the DBS by using a CE marked Medical Device in patients presenting one of the following five disorders: Parkinson's disease (PD), essential tremor (ET), dystonia (DYS), Obsessive compulsive disorder (OCD) and Tourette Syndrome (TS).

The Brain Tissue Imprint project is focused on the DBS surgical procedure, which constitutes an appropriate method to collect brain tissue imprints by taking advantage of the direct and transitory contact at the extremity of the dilator with adjacent brain tissue. Indeed, during this step, micro-fragments of brain material spontaneously adhere to the dilator tip. It is this imprinting process that allows to collect what is defined as "brain tissue imprints. This approach is part of the standard surgical procedure of the SCP without major change or complications.

Conditions

  • Parkinson Disease
  • Neurologic Disorder

Interventions

DEVICE

Brain Tissue Imprint

Brain Tissue Imprint procedure (BTI) is performed during DBS surgery. Before the implantation of the electrode, the surgeon uses a dilator. It is a rigid stylet with a blunt end, intended to prepare the way for the final electrode. This dilator is lowered gently through the cerebral parenchyma up to the target then removed to be replaced by the electrode. In our BTI study, the standard dilator used in DBS surgery will be replaced by a CE marked Medical Device. This brain imprint kit will be used for each hemisphere. The procedure is the following: * The guide tube with the first stylet is set up to the target * Withdrawal of the first stylet and insertion of the second stylet for one minute to have a spontaneous and adequate tissue adhesion * Withdrawal of the guide tube containing the stylet. This last step will prevent contamination of the harvested material on the stylet during the removal.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Stéphan Chabardès, Pr · Grenoble Hospital - Service de Neurochirurgie, CHUGA

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • France

Study Locations

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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 NCT03929406 on ClinicalTrials.gov