Neuromodulation for Hypothalamic Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Deep Brain Stimulation for Hypothalamic Obesity: A Surgical & Neuroimaging Study

Conditions
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Craniopharyngioma, Hypothalamic Obesity, Metabolic Syndrome

Intervention / Treatment
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* Device: Hypothalamic Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with hypothalamic obesity following craniopharyngioma tumour removal Treatment refractory to pharmacological interventions such as growth hormone therapy and anti-obesity medications Exclusion Criteria: Unable to give consent or unmanaged psychiatric condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Lateral Hypothalamic DBS Stimulation<br>Open-label lateral hypothalamic DBS stimulation for 1 year. | Device: Hypothalamic Deep Brain Stimulation<br>* One-year continuous hypothalamic deep brain stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Measuring BMI(kg/m^2) following 12 months of constant stimulation | 12 months | 
| Hyperphagia Questionnaire | Completion of hyperphagia questionnaire | 12 months | 
| SF-36 Quality of Life Questionnaire | Completion of QoL Questionnaire | 12 months |