Essential TremorECOLOVIMNCT05671848
Electroclinical Correlates in Essential Tremor
A study testing Recordings of thalamic activity in people with Essential Tremor, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Recordings of thalamic activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2023to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Activity of the Ventral Intermediate Nucleus of the Thalamus Under Ecological Conditions in Essential Tremor.
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.
Read the 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.
- Conditions
- Essential Tremor
- Being tested
- Recordings of thalamic activity
- Keywords
- Essential Tremor, Local field potentials, Deep Brain Stimulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Patient with ET and Receiving deep brain stimulation treatment with implantation of the PERCEPT™ device Receives: Other: Recordings of thalamic activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months (M6) after surgery (M0)
Secondary outcomes (4)
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.
Measured: 6 months (M6) after surgery (M0)
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.
Measured: 6 months (M6) after surgery (M0)
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.
Measured: 1 month (M1) after surgery (M0)
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.
Measured: 3 months (M3) after surgery (M0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start3 May 2023
- Primary completion16 Jul 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, open-label, prospective cohort pilot study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- MINDig
- Responsible party
- Sponsor
- Investigators
- Dominique GUELH, Pr, Study director, University Hospital, BordeauxEdouard COURTIN, Dr, Principal investigator, University Hospital, BordeauxMahmoud HASSAN, Dr, Study chair, MINDig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671848
- Sponsor's protocol ID
- CHUBX 2022/29
- Acronym
- ECOLOVIM
- Status last verified
- Aug 2026
- First submitted
- 3 Jan 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Activity of the Ventral Intermediate Nucleus of the Thalamus Under Ecological Conditions in Essential Tremor.
- ClinicalTrials.gov ID
- NCT05671848
- Acronym / sponsor ID
- ECOLOVIM / CHUBX 2022/29
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, Local field potentials, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- MINDig
- Study start
- 3 May 2023 (actual)
- Primary completion
- 16 Jul 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, open-label, prospective cohort pilot study.
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Other: Recordings of thalamic activityPatient with ET and Receiving deep brain stimulation treatment with implantation of the PERCEPT™ device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recordings of thalamic activityRecordings 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. | Other | experimental arm |
Primary outcome
Recorded signal quality
Time frame: 6 months (M6) after surgery (M0)
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.
4 secondary outcomes
presence or absence of brain oscillations
Time frame: 6 months (M6) after surgery (M0)
Power spectral density (PSD)
Time frame: 6 months (M6) after surgery (M0)
Location of the electrodes
Time frame: 1 month (M1) after surgery (M0)
Evaluation of the efficacy of VIM DBS in the ET
Time frame: 3 months (M3) after surgery (M0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique GUELH, Pr study director
University Hospital, Bordeaux
Edouard COURTIN, Dr principal investigator
University Hospital, Bordeaux
Mahmoud HASSAN, Dr study chair
MINDig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recordings of thalamic activity in people with Essential Tremor, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recorded signal quality (time frame: 6 months (M6) after surgery (M0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.