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Electroclinical Correlates in Essential Tremor

NCT05671848 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Recordings of thalamic activity

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.

Sponsors & Collaborators

  • MINDig

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Dominique GUELH, Pr · University Hospital, Bordeaux

  • Edouard COURTIN, Dr · University Hospital, Bordeaux

  • Mahmoud HASSAN, Dr · MINDig

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2026-05-03
Completion
2026-05-03

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT05671848 on ClinicalTrials.gov