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Trial record 22 of 101 for:    "Craniopharyngioma"

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Recruitment Status : Withdrawn (no participants have been able to qualify for study)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

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.

Condition or disease Intervention/treatment Phase
Craniopharyngioma Hypothalamic Obesity Metabolic Syndrome Device: Hypothalamic Deep Brain Stimulation Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Hypothalamic Obesity: A Surgical & Neuroimaging Study
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: Open-Label Lateral Hypothalamic DBS Stimulation
Open-label lateral hypothalamic DBS stimulation for 1 year.
Device: Hypothalamic Deep Brain Stimulation
One-year continuous hypothalamic deep brain stimulation




Primary Outcome Measures :
  1. Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: 12 months ]
    Measuring BMI(kg/m^2) following 12 months of constant stimulation

  2. Hyperphagia Questionnaire [ Time Frame: 12 months ]
    Completion of hyperphagia questionnaire

  3. SF-36 Quality of Life Questionnaire [ Time Frame: 12 months ]
    Completion of QoL Questionnaire



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications:
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Responsible Party: Christopher Honey, Professor & Neurosurgeon, University of British Columbia
ClinicalTrials.gov Identifier: NCT03708913     History of Changes
Other Study ID Numbers: H16-01595
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

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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
Additional relevant MeSH terms:
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Craniopharyngioma
Adamantinoma
Obesity
Metabolic Syndrome
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases