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Neuromodulation for Hypothalamic Obesity

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ClinicalTrials.gov Identifier: NCT03708913
Recruitment Status : Withdrawn (no participants have been able to qualify for study)
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Honey, University of British Columbia

Tracking Information
First Submitted Date  ICMJE December 8, 2016
First Posted Date  ICMJE October 17, 2018
Last Update Posted Date October 17, 2018
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
  • Body Mass Index (BMI) [ Time Frame: 12 months ]
    Measuring BMI(kg/m^2) following 12 months of constant stimulation
  • Hyperphagia Questionnaire [ Time Frame: 12 months ]
    Completion of hyperphagia questionnaire
  • SF-36 Quality of Life Questionnaire [ Time Frame: 12 months ]
    Completion of QoL Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromodulation for Hypothalamic Obesity
Official Title  ICMJE Deep Brain Stimulation for Hypothalamic Obesity: A Surgical & Neuroimaging Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Craniopharyngioma
  • Hypothalamic Obesity
  • Metabolic Syndrome
Intervention  ICMJE Device: Hypothalamic Deep Brain Stimulation
One-year continuous hypothalamic deep brain stimulation
Study Arms  ICMJE Experimental: Open-Label Lateral Hypothalamic DBS Stimulation
Open-label lateral hypothalamic DBS stimulation for 1 year.
Intervention: Device: Hypothalamic Deep Brain Stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03708913
Other Study ID Numbers  ICMJE H16-01595
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Honey, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of British Columbia
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP