Brain Tissue Imprint (BTI)

April 25, 2019 updated by: University Hospital, Grenoble

Stimulation cérébrale Profonde et Empreinte Tissulaire : Une Nouvelle stratégie Pour la Recherche Biologique in Vivo Dans la Maladie de Parkinson, Les TOC, la Dystonie, le Tremblement Essentiel et le Syndrome Gilles de la Tourette.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Deep brain stimulation (DBS) has become the standard functional neurosurgery treatment for drug resistant Parkinson's disease (PD) patients. It has also demonstrated its efficacy to treat various movement disorders as well as neurological and psychiatric disorders. The subthalamic nucleus (STN), the globus pallidus internal (GPi) or the ventral intermediate nucleus of the thalamus (VIM) are the major targets of DBS.

Access to pathological brain tissue in living PD patients or other neurological diseases is a key issue for the discovery of new therapeutic targets and the development of potential curative therapies. In this context, DBS offers a unique access to the pathological brain. In the standard surgical procedure, to prepare the way for the final electrode, the surgeon uses a dilator that is lowered gently through the cerebral parenchyma up to the target. It has been shown that during this step, brain tissue fragments adhere to the extremity of the dilator. However, the major drawback of the standard dilator lies in the fact that its end is in contact with several brain regions before reaching the targeted nucleus. Therefore, it is difficult to guarantee the origin of the collected tissue micro-fragments. In order to optimize the specificity of the harvested imprints, the investgator will use a dedicated CE marked medical device that consists of a guide tube and a stylet instead of the dilator used in DBS surgical procedure. The objective of this study is to validate brain tissue imprints collection in PD, ET, DYS, OCD and TS.

The BTI will be specifically collected from the targeted implantation site corresponding to the STN, the GPi and the VIM. Moreover, the tip of the electrode (and therefore the BTI) often reaches the substantia negra pars compacta (SNpc) because of its proximity with the STN. The ability to perform BTI in the SNpc is of highly interest since it is the structure containing the neurons that degenerate gradually and massively throughout the pathological process of Parkinson's disease.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible patients for deep brain stimulation surgery
  • Patients affiliated to social security or benefiting of a similar insurance scheme
  • Patients having signed a consent to participate to the study

Exclusion Criteria:

  • Patient not eligible for deep brain stimulation surgery
  • Pregnant women or nursing mothers
  • Persons deprived of liberty by judicial or administrative decision
  • Persons unable to express their consent or legally protected
  • Persons in period of disqualification for another interventional research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain Tissue Imprint
Evaluation and validation of the samples collected during the brain tissue imprint procedure 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the collection of brain tissue fragments on the BTI device during the DBS surgical procedure
Time Frame: The evaluation of the collection of brain tissue fragments will be performed in the surgery room when the BTI device is removed from the patient and inserted in the collection tube
Visual assessment of the presence or the absence of a tissue micro-fragment. The presence or absence of blood contamination will also be notified
The evaluation of the collection of brain tissue fragments will be performed in the surgery room when the BTI device is removed from the patient and inserted in the collection tube

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Stéphan Chabardès, Pr, Grenoble Hospital - Service de Neurochirurgie, CHUGA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A03001-54

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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