Clinical trial NCT03708913: Neuromodulation for Hypothalamic Obesity
Official title: Deep Brain Stimulation for Hypothalamic Obesity: A Surgical & Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Craniopharyngioma
Hypothalamic Obesity
Metabolic Syndrome
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects
timeFrame: 12 months
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 12 months
measure: Hyperphagia Questionnaire
timeFrame: 12 months
measure: SF-36 Quality of Life Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Leslie and Gordon Diamond Health Center
state: British Columbia
Study officials:
References:
citation: Lustig RH. Hypothalamic obesity after craniopharyngioma: mechanisms, diagnosis, and treatment. Front Endocrinol (Lausanne). 2011 Nov 3;2:60. doi: 10.3389/fendo.2011.00060. eCollection 2011.
citation: Lustig RH. Hypothalamic obesity: causes, consequences, treatment. Pediatr Endocrinol Rev. 2008 Dec;6(2):220-7.
citation: Lustig RH, Post SR, Srivannaboon K, Rose SR, Danish RK, Burghen GA, Xiong X, Wu S, Merchant TE. Risk factors for the development of obesity in children surviving brain tumors. J Clin Endocrinol Metab. 2003 Feb;88(2):611-6. doi: 10.1210/jc.2002-021180.
citation: Lustig RH, Rose SR, Burghen GA, Velasquez-Mieyer P, Broome DC, Smith K, Li H, Hudson MM, Heideman RL, Kun LE. Hypothalamic obesity caused by cranial insult in children: altered glucose and insulin dynamics and reversal by a somatostatin agonist. J Pediatr. 1999 Aug;135(2 Pt 1):162-8. doi: 10.1016/s0022-3476(99)70017-x.
citation: Ho AL, Sussman ES, Zhang M, Pendharkar AV, Azagury DE, Bohon C, Halpern CH. Deep Brain Stimulation for Obesity. Cureus. 2015 Mar 25;7(3):e259. doi: 10.7759/cureus.259. eCollection 2015 Mar.