NCT03708913

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2016

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

December 8, 2016

Last Update Submit

October 29, 2020

Conditions

CraniopharyngiomaHypothalamic ObesityMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (3)

  • Body Mass Index (BMI)

    12 months

  • Hyperphagia Questionnaire

    12 months

  • SF-36 Quality of Life Questionnaire

    12 months

Study Arms (1)

Open-Label Lateral Hypothalamic DBS Stimulation

EXPERIMENTAL

Open-label lateral hypothalamic DBS stimulation for 1 year.

Device: Hypothalamic Deep Brain Stimulation

Interventions

Hypothalamic Deep Brain StimulationDEVICE

One-year continuous hypothalamic deep brain stimulation

Open-Label Lateral Hypothalamic DBS Stimulation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with hypothalamic obesity following craniopharyngioma tumour removal
  • Treatment refractory to pharmacological interventions such as growth hormone therapy and anti-obesity medications

You may not qualify if:

  • Unable to give consent or unmanaged psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leslie and Gordon Diamond Health Center

Vancouver, British Columbia, V5Z1M9, Canada

Location

Related Publications (5)

  • 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.

    PMID: 22654817BACKGROUND

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

    PMID: 19202508BACKGROUND

  • 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.

    PMID: 12574189BACKGROUND

  • 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.

    PMID: 10431109BACKGROUND

  • 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.

    PMID: 26180683BACKGROUND

MeSH Terms

Conditions

CraniopharyngiomaSexual InfantilismMetabolic Syndrome

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueGonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System DiseasesHypogonadismInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Neurosurgeon

Study Record Dates

First Submitted

December 8, 2016

First Posted

October 17, 2018

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations

CA(1)