Back to resultsNeuromodulation for Hypothalamic Obesity
Primary Purpose
Craniopharyngioma, Hypothalamic Obesity, Metabolic Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hypothalamic Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Craniopharyngioma
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
Sites / Locations
- Leslie and Gordon Diamond Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-Label Lateral Hypothalamic DBS Stimulation
Arm Description
Open-label lateral hypothalamic DBS stimulation for 1 year.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects
Secondary Outcome Measures
Body Mass Index (BMI)
Measuring BMI(kg/m^2) following 12 months of constant stimulation
Hyperphagia Questionnaire
Completion of hyperphagia questionnaire
SF-36 Quality of Life Questionnaire
Completion of QoL Questionnaire
Full Information
NCT ID
NCT03708913
First Posted
December 8, 2016
Last Updated
October 29, 2020
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT03708913
Brief Title
Neuromodulation for Hypothalamic Obesity
Official Title
Deep Brain Stimulation for Hypothalamic Obesity: A Surgical & Neuroimaging Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no participants have been able to qualify for study
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniopharyngioma, Hypothalamic Obesity, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-Label Lateral Hypothalamic DBS Stimulation
Arm Type
Experimental
Arm Description
Open-label lateral hypothalamic DBS stimulation for 1 year.
Intervention Type
Device
Intervention Name(s)
Hypothalamic Deep Brain Stimulation
Intervention Description
One-year continuous hypothalamic deep brain stimulation
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
Measuring BMI(kg/m^2) following 12 months of constant stimulation
Time Frame
12 months
Title
Hyperphagia Questionnaire
Description
Completion of hyperphagia questionnaire
Time Frame
12 months
Title
SF-36 Quality of Life Questionnaire
Description
Completion of QoL Questionnaire
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Leslie and Gordon Diamond Health Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22654817
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.
Results Reference
background
PubMed Identifier
19202508
Citation
Lustig RH. Hypothalamic obesity: causes, consequences, treatment. Pediatr Endocrinol Rev. 2008 Dec;6(2):220-7.
Results Reference
background
PubMed Identifier
12574189
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.
Results Reference
background
PubMed Identifier
10431109
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.
Results Reference
background
PubMed Identifier
26180683
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.
Results Reference
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Neuromodulation for Hypothalamic Obesity
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