Pathology Requiring Deep Brain Stimulation TherapyLFP-DBS 2024NCT06813300
Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024
A study testing Electrophysiological recordings in people with Pathology Requiring Deep Brain Stimulation Therapy, run by Centre Hospitalier St Anne at 2 sites in France.
Trial summary
Deep brain stimulation (DBS) is a therapeutic approach aimed at applying high-frequency, low-intensity electrical stimulation using electrodes implanted in subcortical structures and connected subcutaneously to a stimulator implanted in the abdomen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathology Requiring Deep Brain Stimulation Therapy
- What is being tested?
- Electrophysiological recordings
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Sep 2024to 25 Apr 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- Patient suffering from a pathology requiring treatment with deep brain stimulation: neurological disease (e.g.: Parkinson Disease, Essential Tremors, dystonia, epilepsy, etc.) or psychiatric disease (e.g.: Obsessive Compulsive Disorder, depression, eating disorders, etc.).
- Patient capable of understanding the study procedures and completing the self-questionnaires in French
- Patient informed and having signed the informed consent form
Who cannot join
- Contraindications to DBS, neurosurgery or anesthesia
- Patients with significant hemorrhagic or infectious risks
- Patient unable to perform the neurocognitive or sensorimotor tests
- Patient who is not a beneficiary of a social security system.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Grenoble-Alpes Hospital Center
Grenoble, 38043
Mircea POLOSAN, MD, 0033 476765383, MPolosan@chu-grenoble.fr
Mircea POLOSAN, MD
- Recruiting
Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris
Paris, 75014
Khaoussou Sylla, MD, PhD, +33 1 45 65 76 78, K.SYLLA@ghu-paris.fr
Philippe DOMENECH, Professor, MD, PhD
About this study
Deep brain stimulation (DBS) is a therapeutic approach aimed at applying high-frequency, low-intensity electrical stimulation using electrodes implanted in subcortical structures and connected subcutaneously to a stimulator implanted in the abdomen. In recent years, new indications have been studied for severe and drug-resistant forms of several neurological and neuropsychiatric pathologies. Its non-lesional, reversible and customizable nature make it a therapy of choice.
However, several factors are currently slowing down the evolution and optimization of SCP.
The identification of objective, quantifiable and predictive criteria for the therapeutic effects of stimulation would allow an acceleration of the individualized identification of the therapeutic parameters of SCP. The surgical procedure for implanting the stimulation equipment is carried out in several stages, which offer unique opportunities to acquire individual imaging or electrophysiology data that are potentially predictive of the therapeutic effect of DBS. In order to continue the optimization of DBS procedures, and therefore to maximize its therapeutic effects, it seems crucial to us to take advantage of all the neurophysiological data likely to be collected during this procedure. Furthermore, given the multiplication of indications for SCP, it seems necessary to highlight specific markers. Thus, the use of neurocognitive and/or motor tests specific to each pathology and coupled with electrophysiological recordings and anatomical and functional examinations would make it possible to highlight specific functional biomarkers predictive of therapeutic effects.
- Being tested
- Electrophysiological recordings
- Keywords
- DBS, LFP, MUA, MEG, IRM, cognitive tasks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological recordingsProcedure or surgery
Addition of electrophysiological recordings performed during cognitive tasks passation in patients undergoing DBS: in pre-op, per-op, peri-op and post-op setting
| Study group | Role | What they receive |
|---|---|---|
| Cognitive tasks performed during electrophysiological recordings | Experimental | Cognitive tasks performed during neural recordings (MUA, LFP) during the phases of a DBS Receives: Procedure: Electrophysiological recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity recorded by electrophysiological measurements
Electrophysiological variables recorded during neurocognitive and/or sensorimotor tests before and after the DBS procedure (at least 2 months at effective parameters)
Measured: From enrollment through study completion, an average of 2 years
Therapeutic effectiveness of DBS
The effectiveness of DBS is calculated as the differential (in %) of the symptom severity score(s) before and after the DBS procedure, measured using scales specific to each pathology (e.g. MADRS for depression (min score: 0 - max score: 60), YBOCS for OCD (min score: 0- max score: 40). Higher score means worse outcome for both scales.
Measured: From enrollment through study completion, , an average of 2 years
Secondary outcomes (4)
Number of patients with pre operative MRI by intensity
Number of patients with 3 and 7 teslas MRI used before DBS surgery
Measured: Day - 21
Therapeutic effectiveness of DBS
The effectiveness of DBS is calculated as the differential (in %) of the symptom severity score(s) before and after the DBS procedure, measured using scales specific to each pathology.
Measured: From enrollment through study completion, an average of 2 years
Number of participants with correct DBS electrodes implantation
The precision of the implantation of the DBS electrodes evaluated by the therapeutic effect obtained in the pathology treated.
Measured: Day 0
Number of participants with inter-individual reproducibility of electrophysiological responses
The inter-individual reproducibility of electrophysiological responses with a view to the generalization of this type of approach
Measured: From enrollment to the end of study at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start18 Sep 2024
- Primary completion25 Apr 2036 (estimated)
- Study completion25 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathology Requiring Deep Brain Stimulation TherapyStudies 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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813300
- Sponsor's protocol ID
- D24-P005
- Acronym
- LFP-DBS 2024
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2024
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024
- ClinicalTrials.gov ID
- NCT06813300
- Acronym / sponsor ID
- LFP-DBS 2024 / D24-P005
- Keywords
- DBS, LFP, MUA, MEG, IRM, cognitive tasks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 25 Apr 2036 (estimated)
- Study completion
- 25 Apr 2036 (estimated)
- First posted
- 6 Feb 2025 (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.
Deep brain stimulation (DBS) is a therapeutic approach aimed at applying high-frequency, low-intensity electrical stimulation using electrodes implanted in subcortical structures and connected subcutaneously to a stimulator implanted in the abdomen. In recent years, new indications have been studied for severe and drug-resistant forms of several neurological and neuropsychiatric pathologies. Its non-lesional, reversible and customizable nature make it a therapy of choice.
However, several factors are currently slowing down the evolution and optimization of SCP.
The identification of objective, quantifiable and predictive criteria for the therapeutic effects of stimulation would allow an acceleration of the individualized identification of the therapeutic parameters of SCP. The surgical procedure for implanting the stimulation equipment is carried out in several stages, which offer unique opportunities to acquire individual imaging or electrophysiology data that are potentially predictive of the therapeutic effect of DBS. In order to continue the optimization of DBS procedures, and therefore to maximize its therapeutic effects, it seems crucial to us to take advantage of all the neurophysiological data likely to be collected during this procedure. Furthermore, given the multiplication of indications for SCP, it seems necessary to highlight specific markers. Thus, the use of neurocognitive and/or motor tests specific to each pathology and coupled with electrophysiological recordings and anatomical and functional examinations would make it possible to highlight specific functional biomarkers predictive of therapeutic effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive tasks performed during electrophysiological recordings | Experimental | Procedure: Electrophysiological recordingsCognitive tasks performed during neural recordings (MUA, LFP) during the phases of a DBS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- Patient suffering from a pathology requiring treatment with deep brain stimulation: neurological disease (e.g.: Parkinson Disease, Essential Tremors, dystonia, epilepsy, etc.) or psychiatric disease (e.g.: Obsessive Compulsive Disorder, depression, eating disorders, etc.).
- Patient capable of understanding the study procedures and completing the self-questionnaires in French
- Patient informed and having signed the informed consent form
Key exclusion criteria (4 listed)
- Contraindications to DBS, neurosurgery or anesthesia
- Patients with significant hemorrhagic or infectious risks
- Patient unable to perform the neurocognitive or sensorimotor tests
- Patient who is not a beneficiary of a social security system.
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 |
|---|---|---|
| Electrophysiological recordingsAddition of electrophysiological recordings performed during cognitive tasks passation in patients undergoing DBS: in pre-op, per-op, peri-op and post-op setting | Procedure or surgery | Cognitive tasks performed during electrophysiological recordings |
Primary outcome
Brain activity recorded by electrophysiological measurements
Time frame: From enrollment through study completion, an average of 2 years
Electrophysiological variables recorded during neurocognitive and/or sensorimotor tests before and after the DBS procedure (at least 2 months at effective parameters)
Therapeutic effectiveness of DBS
Time frame: From enrollment through study completion, , an average of 2 years
The effectiveness of DBS is calculated as the differential (in %) of the symptom severity score(s) before and after the DBS procedure, measured using scales specific to each pathology (e.g. MADRS for depression (min score: 0 - max score: 60), YBOCS for OCD (min score: 0- max score: 40). Higher score means worse outcome for both scales.
4 secondary outcomes
Number of patients with pre operative MRI by intensity
Time frame: Day - 21
Therapeutic effectiveness of DBS
Time frame: From enrollment through study completion, an average of 2 years
Number of participants with correct DBS electrodes implantation
Time frame: Day 0
Number of participants with inter-individual reproducibility of electrophysiological responses
Time frame: From enrollment to the end of study at 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological recordings in people with Pathology Requiring Deep Brain Stimulation Therapy, run by Centre Hospitalier St Anne at 2 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Domenech, Professor, MD, PhD (0033(0)149812201, philippe.domenech@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity recorded by electrophysiological measurements (time frame: From enrollment through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 18 Sep 2026.