Parkinson DiseaseLFP-DBSNCT03874611
Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation
A study testing electrophysiological data from DBS in people with Parkinson Disease and Obsessive-Compulsive Disorder, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Primary objective Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease, Obsessive-Compulsive Disorder, Epilepsy
- What is being tested?
- electrophysiological data from DBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2011to 31 Mar 2021
- 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
- Pathology requiring brain stimulation therapy (criteria of severity, therapeutic resistance and severity of disability): motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders (eg OCD, depression).
- These pathologies therefore include motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders that can be treated with brain stimulation therapy. Note that these are independent of motor disorders. The inclusion criteria obviously depend on the pathology.
- As an example for a motor pathology treated by stimulation, in Parkinson's disease the following inclusion criteria are used :
- patients aged 18 to 75 and affiliated to a social security scheme
- Idiopathic Parkinson's disease that meets the United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria or suffering from recessive autosomal juvenile parkinsonism
- duration of evolution of the disease> 5 years
Show all 31Show fewer
- stage of severe motor complications of levodopa despite optimal treatment.
- For dystonic patients, the following inclusion criteria are used :
- Disabling dystonia (severe focal, segmental or generalized).
- Patient ≥ 18 years of age and under age 65
- Duration of evolution of dystonia greater than one year.
- For patients with obsessive-compulsive disorder (OCD), the following inclusion criteria are used :
- OCD which has been diagnosed for at least 5 years according to the DSM-IV criteria as OCD with "good insight", confirmed using the Diagnostic Interview Genetic Study (DIGS) - OCD section ; score below the delusional idea threshold at the BABS (Brown Assessment of Beliefs Scale) insight scale (Eisen, Phillips et al., 1998)
- OCD of severe intensity (total YBOCS > 25, or subscale Obsessions or Compulsions > 15, EGF < 40, CGI > 4) with prognosis considered to be bad in the absence of intervention
- Non-responder OCD (an improvement of less than 25% on the Y-BOCS scale) to at least three IRS-type antidepressants, including clomipramine, used sequentially at the maximum tolerated dose for at least 12 weeks. Used alone and in combination for at least 1 month with risperidone or pimozide and any of the following products : lithium salts or clonazepam or buspirone or pindolol (Greist and Jefferson 1998) (McDougle, Epperson et al 2000) (Dannon , Sasson et al., 2000)
- OCD having benefited from Behavioral and Cognitive Therapy for at least 1 year (application of classical programs, including exposure techniques with prevention of ritualized response, with at least two sessions per month).
- Patient between 18 and 60 years of age who has given his signature and informed consent after receiving written information on the proposed procedure
- Sick with social security
- For patients with depressive illness, the following inclusion criteria were used :
- male or female between the ages of 30 and 65
- with a diagnosis of unipolar major depression (MINI) resistant to conventional treatments
- Hamilton and Montgomery Depression Scale (HAMD) score> 20
- Duration of the current depressive episode of more than 12 months, the patient being included in a care system has established the chronic and recurrent state of this depression,
- Ineffective treatment of the current episode with at least 4 therapeutic attempts including antidepressant drug monotherapy treatments (MAOIs, tricyclic antidepressants, selective serotonin reuptake inhibitors, mixed serotonin reuptake inhibitors, and norepinephrine), the potentiations of antidepressant treatments (by lithium salts, thyroid hormones or neuroleptics), the psychotherapies structured according to validated techniques, the ECT carried out under conditions in conformity with the recommendations (ANAES, 1998) (at least 6 sessions in technical bilateral with control of duration of seizure)
- Women of childbearing age should follow a contraceptive method that is considered sufficiently effective by the investigator. In this case a pregnancy test will be performed on inclusion
- outpatient or inpatient
- fluent in the French language and able to understand the procedures of the study and in particular complete the self-questionnaires used
- Patient likely to give informed consent
- Patient affiliated with Social Security
- Patient's written agreement to participate in the study
- Intellectual abilities compatible with cognitive or motor tasks
Who cannot join
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble-Alpes
Grenoble
Stephan CHABARDES, Pr, 04 76 76 75 59
Julien Bastin, Dr, 04 56 52 06 78, Julien.Bastin@univ-grenoble-alpes.fr
About this study
Primary objective
Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy.
Read more
Research hypotheses
The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of the activity, locally and on a large scale, of functional cortical-subcortical networks showing pathological behavior beforehand. The electrophysiological measurements in response to different tasks make it possible to highlight precise dysfunctions of these neural networks, in relation with the behavioral and / or motor disorders associated with the pathologies treated by DBS.
Consequently, we hypothesize that the exploitation of electrophysiological responses during cognitive or sensorimotor tasks performed during the implantation procedure of stimulation electrodes in patients treated with DBS will allow :
- To collect fundamental data to understanding the physiological functioning of basal ganglia in humans ;
- To collect functional markers from the operating room in relation to the symptoms targeted by the DBS that will help in the choice of implantation site of the stimulation electrode ;
- Define long-term predictive markers of DBS effects by comparing electrophysiological effects measured post-operatively and clinical scores under DBS.
- Conditions
- Parkinson Disease, Obsessive-Compulsive Disorder, Epilepsy, Depression
- Being tested
- electrophysiological data from DBS
- Medical subject headings
- Parkinson Disease, Obsessive-Compulsive Disorder, Epilepsy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiological data from DBSOther
For each selected patient, the evaluation of cognitive or sensory-motor functions by electrophysiology will be conducted in the operating room, preoperatively the week before implantation and post-operatively within five days between the implantation of deep electrodes and the setting of the stimulator.
| Study group | Role | What they receive |
|---|---|---|
| electrophysiological data from DBS | Experimental | Not described Receives: Other: electrophysiological data from DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
The latency of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
Measured: 5 days
Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
The amplitude of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
Measured: 5 days
Secondary outcomes (3)
cognitive and sensorimotor tasks
percentage of electrode contacts within a given brain area that will display task-evoked neural responses (as assessed by time-frequency analyses) for a given task.
Measured: 5 days
functional atlas of basal ganglia
statistical effects of each task as assessed by t-tests performed across patient's task-related electrophysiological responses (as assessed by time-frequency analyses).
Measured: 5 days
number of electrophysiological responses
time and frequency analyses
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start13 Apr 2011
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874611
- Sponsor's protocol ID
- 38RC11.242
- Acronym
- LFP-DBS
- Status last verified
- Jun 2018
- First submitted
- 30 Apr 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT03874611
- Acronym / sponsor ID
- LFP-DBS / 38RC11.242
- Conditions
- Parkinson Disease, Obsessive-Compulsive Disorder, Epilepsy, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Apr 2011 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 14 Mar 2019 (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.
Primary objective
Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy.
Research hypotheses
The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of the activity, locally and on a large scale, of functional cortical-subcortical networks showing pathological behavior beforehand. The electrophysiological measurements in response to different tasks make it possible to highlight precise dysfunctions of these neural networks, in relation with the behavioral and / or motor disorders associated with the pathologies treated by DBS.
Consequently, we hypothesize that the exploitation of electrophysiological responses during cognitive or sensorimotor tasks performed during the implantation procedure of stimulation electrodes in patients treated with DBS will allow :
- To collect fundamental data to understanding the physiological functioning of basal ganglia in humans ;
- To collect functional markers from the operating room in relation to the symptoms targeted by the DBS that will help in the choice of implantation site of the stimulation electrode ;
- Define long-term predictive markers of DBS effects by comparing electrophysiological effects measured post-operatively and clinical scores under DBS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrophysiological data from DBS | Experimental | Other: electrophysiological data from DBS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Pathology requiring brain stimulation therapy (criteria of severity, therapeutic resistance and severity of disability): motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders (eg OCD, depression).
- These pathologies therefore include motor disorders (eg Parkinson's disease, dystonia) or psychiatric disorders that can be treated with brain stimulation therapy. Note that these are independent of motor disorders. The inclusion criteria obviously depend on the pathology.
- As an example for a motor pathology treated by stimulation, in Parkinson's disease the following inclusion criteria are used :
- patients aged 18 to 75 and affiliated to a social security scheme
- Idiopathic Parkinson's disease that meets the United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria or suffering from recessive autosomal juvenile parkinsonism
Key exclusion criteria (1 listed)
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP.
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 data from DBSFor each selected patient, the evaluation of cognitive or sensory-motor functions by electrophysiology will be conducted in the operating room, preoperatively the week before implantation and post-operatively within five days between the implantation of deep electrodes and the setting of the stimulator. | Other | electrophysiological data from DBS |
Primary outcome
Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
Time frame: 5 days
The latency of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
Number of functional markers derived from electrophysiological signals recorded during cognitive tests.
Time frame: 5 days
The amplitude of task-related electrophysiological responses derived from deep brain electrodes, as assessed by time-frequency and evoked-responses analyses.
3 secondary outcomes
cognitive and sensorimotor tasks
Time frame: 5 days
functional atlas of basal ganglia
Time frame: 5 days
number of electrophysiological responses
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrophysiological data from DBS in people with Parkinson Disease and Obsessive-Compulsive Disorder, run by University Hospital, Grenoble 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 31 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier David, Dr (04 56 52 05 86, Olivier.David@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of functional markers derived from electrophysiological signals recorded during cognitive tests. (time frame: 5 days). 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 14 Mar 2019.