Cluster HeadacheDBS V3NCT02782533
DBS of the Third Ventricle for Cluster Headache and Obesity
A study testing Deep Brain Stimulation V3 in people with Cluster Headache and Obesity, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache, Obesity
- What is being tested?
- Deep Brain Stimulation V3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 65 years
- Ambulatory or hospitalized monitoring
- Fluent in French and able to understand the study procedures, including completing the auto-questionnaires
- Registered in the French social security scheme
- Signed informed consent of the patient will be collected before inclusion in the study
- Cluster Headache or Obesity patients
Who cannot join
- Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
- Contraindication to Magnetic resonance imaging (MRI)
- All categories of protected persons
Trial locations and contacts
1 site in 1 country.
About this study
Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.
- Conditions
- Cluster Headache, Obesity
- Being tested
- Deep Brain Stimulation V3
- Medical subject headings
- Cluster Headache, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation V3Device
| Study group | Role | What they receive |
|---|---|---|
| DBS V3 | Experimental | Deep Brain Stimulation V3 Receives: Device: Deep Brain Stimulation V3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
Measured: weekly up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startNov 2008
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782533
- Sponsor's protocol ID
- CHU Grenoble
- Acronym
- DBS V3
- Status last verified
- Jul 2018
- First submitted
- 12 May 2016
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DBS of the Third Ventricle for Cluster Headache and Obesity
- ClinicalTrials.gov ID
- NCT02782533
- Acronym / sponsor ID
- DBS V3 / CHU Grenoble
- Conditions
- Cluster Headache, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 25 May 2016 (estimated)
- 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.
Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS V3 | Experimental | Device: Deep Brain Stimulation V3Deep Brain Stimulation V3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged between 18 and 65 years
- Ambulatory or hospitalized monitoring
- Fluent in French and able to understand the study procedures, including completing the auto-questionnaires
- Registered in the French social security scheme
- Signed informed consent of the patient will be collected before inclusion in the study
Key exclusion criteria (3 listed)
- Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
- Contraindication to Magnetic resonance imaging (MRI)
- All categories of protected persons
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 |
|---|---|---|
| Deep Brain Stimulation V3 | Device | DBS V3 |
Primary outcome
Quality of Life Questionnaire
Time frame: weekly up to 3 years
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 19 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation V3 in people with Cluster Headache and Obesity, 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 6 inclusion and 3 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 19 Jul 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?
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?
Quality of Life Questionnaire (time frame: weekly up to 3 years). 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 19 Jul 2019.