NCT05671848

Brief Summary

Essential tremor (ET) is a neurological disorder that affects nearly 0.9% of the world's population. High-frequency Deep Brain Stimulation (DBS) of the ventral-intermediate nuclei of the thalamus (VIM) has been proven as an effective second-line treatment for severe forms of ET. The arrival on the market of the PERCEPT™ (new stimulator/recorder, Medtronic, Minneapolis, USA) now allows, in addition to the stimulation delivery, the recording of intracerebral activity at a distance from surgery, in a non-invasive way and in ecological condition at home. Investigators aim at recording the variations of thalamic Local Field Potentials (LFP) oscillations, in ecological condition, during rest and movement, with and without deep brain stimulation, once a week, between M3 and M6 post surgery.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 3, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2026

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

January 3, 2023

Last Update Submit

October 29, 2024

Conditions

Essential Tremor

Keywords

Essential TremorLocal field potentialsDeep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Recorded signal quality

    The primary endpoint of this study will be the recorded signal quality, i.e., the ratio of signal amplitude (thalamic oscillations) to noise (artifacts) at least 3/1.

    6 months (M6) after surgery (M0)

Secondary Outcomes (4)

  • presence or absence of brain oscillations

    6 months (M6) after surgery (M0)

  • Power spectral density (PSD)

    6 months (M6) after surgery (M0)

  • Location of the electrodes

    1 month (M1) after surgery (M0)

  • Evaluation of the efficacy of VIM DBS in the ET

    3 months (M3) after surgery (M0)

Study Arms (1)

experimental arm

EXPERIMENTAL

Patient with ET and Receiving deep brain stimulation treatment with implantation of the PERCEPT™ device

Other: Recordings of thalamic activity

Interventions

Recordings of thalamic activityOTHER

Recordings of thalamic activity will be performed at home, in ecological conditions. They will be realized during 4 distinct conditions each week between M3 and M6 post implantation: at rest and during tremor-induced movements. For these recordings, stimulation will be either turned Off or On. Three successive recordings of 30 seconds separated by 1 minute will be made for each condition.

experimental arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced disabling and drug-resistant tremor
  • Receiving deep brain stimulation treatment with implantation of the PERCEPT™ device according to standard care
  • Chronic progressive cardiac, renal, hematological or pulmonary diseases under treatment.
  • Patient aged between 18 to 75 years
  • Normal brain MRI
  • MATTIS score ≥ 130/144 or MOCA ≥ 24/30
  • Subject affiliated with or benefiting from a social security plan

You may not qualify if:

  • Major depressive syndrome (Beck scale \> 20)
  • MRI showing significant brain atrophy or significant hypersignals
  • Pregnant or breastfeeding women
  • Being unable to give personal consent
  • Be subject to a measure of legal protection (curatorship, guardianship) or placed under judicial protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Dominique GUELH, Pr

    University Hospital, Bordeaux

    STUDY DIRECTOR

  • Edouard COURTIN, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Mahmoud HASSAN, Dr

    MINDig

    STUDY CHAIR

Central Study Contacts

Edouard COURTIN, Dr

CONTACT

05 57 82 12 42edouard.courtin@chu-bordeaux.fr

Olivier Branchard

CONTACT

05 57 82 06 97olivier.branchard@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single-center, open-label, prospective cohort pilot study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

May 3, 2023

Primary Completion

May 3, 2026

Study Completion

May 3, 2026

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)