Skip to main content
Clinical Trials/NCT03708913
NCT03708913
Withdrawn
Not Applicable

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

University of British Columbia1 site in 1 countryJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Craniopharyngioma
Sponsor
University of British Columbia
Locations
1
Primary Endpoint
Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
April 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Honey

Professor & Neurosurgeon

University of British Columbia

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

Outcomes

Primary Outcomes

Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects

Time Frame: 12 months

Secondary Outcomes

  • Hyperphagia Questionnaire(12 months)
  • SF-36 Quality of Life Questionnaire(12 months)
  • Body Mass Index (BMI)(12 months)

Study Sites (1)

Loading locations...

Similar Trials