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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03708913
Other study ID # H16-01595
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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