Prader-Willi SyndromePhase 1DBSPWNCT02297022
Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
A Phase 1 study testing Deep Brain Stimulation in people with Prader-Willi Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Oct 2016
- Phase
- Phase 1
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 15 years or older
- Parents able to give informed consent
- Diagnosis of Prader-Willi syndrome confirmed by genetic analysis
- Refractoriness to medical treatment, defined as a weight loss lower than 10% of the body weight with nutritional, pharmacological or surgical interventions
- Severe or morbid obesity
- No contra-indications to the surgical procedure
Who cannot join
- Cardiovascular disease that might significantly increase the surgical risk
- Brain lesions detected clinically or during MRI
- Use of cardiac pacemakers/ defibrillators
- Clinical conditions that may require the use of MRI in the post-operative period
- Patients undergoing chemotherapy or immunosuppressive treatments
- Patients unable to return to the hospital at the required intervals
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- Previous neurosurgical treatments that may increase the risk of DBS surgery
- Active medical conditions that may require in-hospital treatment in the nearby future
- Previous diagnosis of epilepsy or status epilepticus
- Chronic infection
- Plan to use diathermy
- Metallic implants that might preclude MRI imaging of the brain
- Active participation in other experimental studies
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
HCFUMSP
São Paulo, São Paulo, 0543-010
Ruth Franco, 55-11 2661-6106, franco-ruth@uol.com.br
Erich Fonoff, 55-11 2661-6106, fonoffet@usp.br
About this study
Official title: Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment.
Read the detailed description
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment. Patients will be implanted with hypothalamic DBS electrodes. Calorimetric and anthropometric measures, body mass index, side effects, neuropsychiatric evaluations will be carried out at 6 months for measuring primary and secondary outcome. Side effects will be monitored at 1, 3, 6 and 12 months following surgery.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, obesity, Prader-Willi syndrome
- Medical subject headings
- Prader-Willi Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Patients with Prader-Willi syndrome to receive DBS. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
waist circumference; mid-upper arm circumference
Measured: 6 months
resting energy expenditure
Measured: 6 months
Body mass index
Measured: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 6 months
Secondary outcomes (4)
daily food ingestion diary listing
Measured: 6 months
Child Yale-Brown Obsessive Compulsive Scale
Measured: 6 months
Child Behaviour Checklist
Measured: 6 months
Feeding Behaviour Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Durval Damiani, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297022
- Sponsor's protocol ID
- InternalFunds
- Acronym
- DBSPW
- Status last verified
- Nov 2014
- First submitted
- 30 Oct 2014
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT02297022
- Acronym / sponsor ID
- DBSPW / InternalFunds
- Conditions
- Prader-Willi Syndrome
- Keywords
- Deep Brain Stimulation, obesity, Prader-Willi syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 21 Nov 2014 (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.
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment.
Detailed description
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment. Patients will be implanted with hypothalamic DBS electrodes. Calorimetric and anthropometric measures, body mass index, side effects, neuropsychiatric evaluations will be carried out at 6 months for measuring primary and secondary outcome. Side effects will be monitored at 1, 3, 6 and 12 months following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationPatients with Prader-Willi syndrome to receive DBS. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 15 years or older
- Parents able to give informed consent
- Diagnosis of Prader-Willi syndrome confirmed by genetic analysis
- Refractoriness to medical treatment, defined as a weight loss lower than 10% of the body weight with nutritional, pharmacological or surgical interventions
- Severe or morbid obesity
Key exclusion criteria (13 listed)
- Cardiovascular disease that might significantly increase the surgical risk
- Brain lesions detected clinically or during MRI
- Use of cardiac pacemakers/ defibrillators
- Clinical conditions that may require the use of MRI in the post-operative period
- Patients undergoing chemotherapy or immunosuppressive treatments
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 StimulationDeep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome | Device | Deep Brain Stimulation |
Primary outcome
waist circumference; mid-upper arm circumference
Time frame: 6 months
resting energy expenditure
Time frame: 6 months
Body mass index
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 months
4 secondary outcomes
daily food ingestion diary listing
Time frame: 6 months
Child Yale-Brown Obsessive Compulsive Scale
Time frame: 6 months
Child Behaviour Checklist
Time frame: 6 months
Feeding Behaviour Questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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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.
Durval Damiani principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep Brain Stimulation in people with Prader-Willi Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 13 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 16 Dec 2015. 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 Brazil. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Juliana Yamashita (551130617672, juliana.yamashita@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waist circumference; mid-upper arm circumference (time frame: 6 months). The study lists 5 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 16 Dec 2015.