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Electroclinical Correlates in Essential Tremor (ECOLOVIM)

Primary Purpose

Essential Tremor

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recordings of thalamic activity
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Essential Tremor focused on measuring Essential Tremor, Local field potentials, Deep Brain Stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Subject affiliated with or benefiting from a social security plan Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) Exclusion Criteria: 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.

Sites / Locations

  • CHU de BordeauxRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

presence or absence of brain oscillations
Good reproducibility of the electrical signals based on the ability to visually individualize, from successive recordings, the presence or absence of brain oscillations in the different frequency bands of interest (peaks on the power spectrum). For this purpose, the intra-patient reproducibility of the spectral powers at rest and in activity will be estimated using Cohen's Kappa coefficient and its two-sided 95% confidence interval according to the exact binomial law.
Power spectral density (PSD)
Analysis of the amplitude of the average PSDs in the 2 distinct motor conditions (rest/movement) and in the 2 stimulation conditions (inactive/active). A difference in PSD amplitude of 15% between the 4 situations is necessary to conclude to significant differences.
Location of the electrodes
Position of the electrodes and the contacts used for the LFP recordings will be analyzed. These contacts will need to be positioned in each VIM that are the targets of deep brain stimulation in the ET.
Evaluation of the efficacy of VIM DBS in the ET
A 50% reduction in clinical scores at M3 compared to the pre-operative scores (M-1) is necessary to conclude that deep brain stimulation of VIM is significantly effective on tremor.

Full Information

First Posted
January 3, 2023
Last Updated
August 2, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
MINDig
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1. Study Identification

Unique Protocol Identification Number
NCT05671848
Brief Title
Electroclinical Correlates in Essential Tremor
Acronym
ECOLOVIM
Official Title
Study of the Activity of the Ventral Intermediate Nucleus of the Thalamus Under Ecological Conditions in Essential Tremor.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
MINDig

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Essential tremor (ET) is a neurological disorder that affects nearly 0.9% of the world's population, including 300,000 people in France alone. Patients who suffer from this condition usually present an upper limb tremor during voluntary motor activities but not at rest. The pharmacological treatments proposed for this condition are only effective in about 50% of patients, and this effectiveness is often only partial or observed at the cost of unacceptable side effects. Since the end of the 1980's, high-frequency deep brain stimulation (DBS) of the ventral-intermediate nuclei of the thalamus (VIM) has been proposed as an effective second-line treatment for severe forms of ET. However, some neuro-stimulated patients experience a recurrence of their tremor and may complain of an increase in pre-existing cerebellar ataxia. The mechanisms underlying these phenomena are still debated, but the fact that VIM stimulation is applied in a chronic and undifferentiated manner seems to play a determining role. One way to circumvent these phenomena could be to stimulate the VIM only during movement since the tremor in this condition is an action or postural tremor. This type of "closed-loop therapy" requires one or more intracerebral tremor biomarkers that can be reliably recognized and used to automatically trigger or modulate the intensity of VIM stimulation only when necessary. In a preliminary study in 10 patients, the investigators of Bordeaux university hospital were able to demonstrate the existence of potential intracerebral biomarkers of tremor under experimental conditions,in the immediate postoperative period (Guehl et al. 2022, submitted). The arrival on the market of the PERCEPT™ (new stimulator/recorder, Medtronic, Minneapolis, USA) now allows, in addition to treating patients with DBS, the recording of intracerebral activity at a distance from surgery, in a non-invasive way and in ecological condition at home. This study aim at recording the variations of thalamic oscillations, in ecological condition, during rest and movement, with and without deep brain stimulation. These measurements will be performed once a week during the 12 weeks of the late post-operative period (from 3 to 6 months), in order to ensure the reproducibility of the results. The signal processing and analysis will be performed in a blind manner to the patient's activity and stimulation condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Essential Tremor, Local field potentials, Deep Brain Stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center, open-label, prospective cohort pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental arm
Arm Type
Experimental
Arm Description
Patient with ET and Receiving deep brain stimulation treatment with implantation of the PERCEPT™ device
Intervention Type
Other
Intervention Name(s)
Recordings of thalamic activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recorded signal quality
Description
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.
Time Frame
6 months (M6) after surgery (M0)
Secondary Outcome Measure Information:
Title
presence or absence of brain oscillations
Description
Good reproducibility of the electrical signals based on the ability to visually individualize, from successive recordings, the presence or absence of brain oscillations in the different frequency bands of interest (peaks on the power spectrum). For this purpose, the intra-patient reproducibility of the spectral powers at rest and in activity will be estimated using Cohen's Kappa coefficient and its two-sided 95% confidence interval according to the exact binomial law.
Time Frame
6 months (M6) after surgery (M0)
Title
Power spectral density (PSD)
Description
Analysis of the amplitude of the average PSDs in the 2 distinct motor conditions (rest/movement) and in the 2 stimulation conditions (inactive/active). A difference in PSD amplitude of 15% between the 4 situations is necessary to conclude to significant differences.
Time Frame
6 months (M6) after surgery (M0)
Title
Location of the electrodes
Description
Position of the electrodes and the contacts used for the LFP recordings will be analyzed. These contacts will need to be positioned in each VIM that are the targets of deep brain stimulation in the ET.
Time Frame
1 month (M1) after surgery (M0)
Title
Evaluation of the efficacy of VIM DBS in the ET
Description
A 50% reduction in clinical scores at M3 compared to the pre-operative scores (M-1) is necessary to conclude that deep brain stimulation of VIM is significantly effective on tremor.
Time Frame
3 months (M3) after surgery (M0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Subject affiliated with or benefiting from a social security plan Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edouard COURTIN, Dr
Phone
05 57 82 12 42
Ext
+33
Email
edouard.courtin@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Branchard
Phone
05 57 82 06 97
Ext
+33
Email
olivier.branchard@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique GUELH, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Edouard COURTIN, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahmoud HASSAN, Dr
Organizational Affiliation
MINDig
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard COURTIN, Dr
Phone
05 57 82 12 42
Ext
+33
Email
edouard.courtin@chu-bordeaux.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Electroclinical Correlates in Essential Tremor

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