Neuromodulation for Hypothalamic Obesity

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03708913
• Other study ID #: H16-01595
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: October 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniopharyngioma
• Hypothalamic Obesity
• Metabolic Syndrome
• Obesity

Intervention

Device:
• Hypothalamic Deep Brain Stimulation
One-year continuous hypothalamic deep brain stimulation

Locations

Country	Name	City	State
Canada	Leslie and Gordon Diamond Health Center	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View Citation

Lustig RH. Hypothalamic obesity: causes, consequences, treatment. Pediatr Endocrinol Rev. 2008 Dec;6(2):220-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects		12 months
Secondary	Body Mass Index (BMI)	Measuring BMI(kg/m^2) following 12 months of constant stimulation	12 months
Secondary	Hyperphagia Questionnaire	Completion of hyperphagia questionnaire	12 months
Secondary	SF-36 Quality of Life Questionnaire	Completion of QoL Questionnaire	12 months