Neuromodulation for Hypothalamic Obesity

Not Applicable

Withdrawn

• Conditions: Craniopharyngioma; Hypothalamic Obesity; Metabolic Syndrome
• Interventions: Device: Hypothalamic Deep Brain Stimulation

• Registration Number: NCT03708913
• Lead Sponsor: University of British Columbia

Brief Summary

The balance between hunger and satiety is imperative for an individual's survival and overall health.). Without this balance, individuals can become morbidly obese or lack adequate nutrition for survival. Craniopharyngioma (CP) is a benign tumour that occurs at the base of the brain in children. Unfortunately, pediatric neurosurgeons sometimes inadvertently destroy a child's satiety centre during CP tumour removal surgery. This leaves the child with a post-operative complication: an insatiable appetite. This form of obesity is called "hypothalamic obesity". This study is designed to investigate Deep Brain Stimulation for hypothalamic obesity in n=6 young adults who have stabilized tumours.

Detailed Description

For young adults with destroyed satiety centres due to childhood CP surgery, we believe directly re-balancing the brain's control of hunger and satiety is necessary for sustained and long-term therapy. n=6 patients will be recruited in this Phase 1 DBS trial. The proposed research will hope to improve personal health among the young adults involved in this study by improving quality of life and avoiding long-term cardiovascular morbidities. Furthermore, this study will elucidate what brain regions drive excessive hunger and develop a treatment that attempts to reverse these abnormalities.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2019-06-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-04-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosed with hypothalamic obesity following craniopharyngioma tumour removal
• Treatment refractory to pharmacological interventions such as growth hormone therapy and anti-obesity medications

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Exclusion Criteria

• Unable to give consent or unmanaged psychiatric condition

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Lateral Hypothalamic DBS Stimulation	Hypothalamic Deep Brain Stimulation	Open-label lateral hypothalamic DBS stimulation for 1 year.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects	12 months

Secondary Outcome Measures

Name	Time	Method
Hyperphagia Questionnaire	12 months	Completion of hyperphagia questionnaire
SF-36 Quality of Life Questionnaire	12 months	Completion of QoL Questionnaire
Body Mass Index (BMI)	12 months	Measuring BMI(kg/m\^2) following 12 months of constant stimulation

Trial Locations

Locations (1)

Leslie and Gordon Diamond Health Center; 🇨🇦 Vancouver, British Columbia, Canada