NCT01793766

Brief Summary

This is a study of overweight men and women. Everybody will receive a very low calorie diet to eat in place of meals for 10 weeks. During the last two weeks of the diet, half of the patients will receive an intervention to activate parts of their brain that can help them eat less. The other half of the patient will receive a placebo or sham intervention. The intervention will involve a small electric current given every day for 10 days. Everybody will be monitored for 16 more weeks (total of 26 weeks) while on a weight maintenance diet to see if the intervention helps people keep the weight off.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started May 2013

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

February 8, 2013

Last Update Submit

October 27, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in weight from week 11 to 26

    Patients will be placed on a very low calorie diet from baseline to week 11. The primary end point is the maintenance of weight loss from week 11 to week 26 after the very low calorie diet is stopped.

    Week 11 to 26

Secondary Outcomes (4)

  • Change in appetite hormones on mixed meal challenge test

    Week 0 to 8, 11 and 26

  • Change in appetite

    Week 0 to 8, 11, 18 and 26

  • Change in body composition

    Week 0 to 8 and 26

  • Change in metabolic parameters

    Week 0 to 8, 11, 18, 26

Study Arms (2)

Brain modulation

EXPERIMENTAL

10 sessions of brain modulation with Eldith/Neuroconn transcranial Direct Current Stimulation device

Device: Brain modulation

Placebo (sham modulation)

PLACEBO COMPARATOR

10 placebo sessions where no brain modulation takes place

Device: Sham modulation

Interventions

Brain modulationDEVICE

Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device

Brain modulation
Sham modulationDEVICE
Placebo (sham modulation)

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women age 20-55 years old
  • BMI 30-50 kg/m2
  • Willing to undergo 10 week supervised VLCD

You may not qualify if:

  • Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
  • Subjects who have a known history of diabetes, fasting blood sugar \>125 mg/dl or using any anti-diabetic drugs
  • Changes in lipid lowering or anti-hypertensive regimen within 3 months of screening
  • Hemoglobin \<10 g/dL, Creatinine \>1.5 mg/dL
  • QT interval \>440 ms on EKG
  • Subjects with unstable psychiatric conditions as assessed by a psychologist
  • Allergy or intolerance to components of the mixed meal challenge
  • Additional contraindications to receive transcranial direct current stimulation (tDCS):
  • Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
  • Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
  • Prior neurosurgical procedure or radiation treatment to the brain.
  • Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
  • Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt or any metallic implant on the head.
  • (Note: Intake of centrally acting medications will be allowed, as there is no evidence that any medication can increase the risk of adverse effects during tDCS.)
  • Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Takara Stanley, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Miguel Alonso-Alonso, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

  • Winfield S. Butsch, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 18, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)