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Neuromodulation for Hypothalamic Obesity

NCT ID: NCT03708913

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-04-01

Brief Summary

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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

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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.

Conditions

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Craniopharyngioma Hypothalamic Obesity Metabolic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-Label Lateral Hypothalamic DBS Stimulation

Open-label lateral hypothalamic DBS stimulation for 1 year.

Group Type EXPERIMENTAL

Hypothalamic Deep Brain Stimulation

Intervention Type DEVICE

One-year continuous hypothalamic deep brain stimulation

Interventions

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Hypothalamic Deep Brain Stimulation

One-year continuous hypothalamic deep brain stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Christopher Honey

Professor & Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Leslie and Gordon Diamond Health Center

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 22654817 (View on PubMed)

Lustig RH. Hypothalamic obesity: causes, consequences, treatment. Pediatr Endocrinol Rev. 2008 Dec;6(2):220-7.

Reference Type BACKGROUND
PMID: 19202508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12574189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10431109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26180683 (View on PubMed)

Other Identifiers

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H16-01595

Identifier Type: -

Identifier Source: org_study_id