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Role of Transcranial Direct Current Stimulation in Appetite and Weight Control (TDCS)

Primary Purpose

Weight Loss, Appetite Loss

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring TDCS, Obesity, Appetite, Weight loss

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and women 18 to 80 years of age Body mass index > 30 kg/m2 Exclusion Criteria: Current participation in any other concurrent clinical trials or previous participation within 30 days before the screening visit Pregnancy or premenopausal women who are trying to be pregnant Patients who are incompetent to give consent Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery Have taken any of the following medications within the past 3 months: phentermine, naltrexone, bupropion, topiratmate, lorcaserin, phendimetrazine, methamphetamine, benzphetamine, diethylpropion Any contraindication 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. Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, Transcutaneous Electrical Nerve Stimulation unit, ventriculo-peritoneal shunt or any metallic implant on the head.

Sites / Locations

  • ECMC Ambulatory Center, 3rd Floor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active tDCS

sham tDCS

Arm Description

This group will receive 30 minutes of active stimulation from tDCS

This group will receive 30 minutes of sham (placebo) stimulation from tDCS

Outcomes

Primary Outcome Measures

change in weight
change in weight, measured as a percentage of baseline body weight

Secondary Outcome Measures

Personality
Personality measured by Big Five inventory personality questionnaire. The result presented on a scale from 1 to 10. IF your score was 10 - it means that your trait is stronger than 97,72%. High score correlates with inventiveness and intellectual curiosity, low score correlates with consistency and curiosity
insulin sensitivity
measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance
Cognitive response to food measured by computer tasks
response to food over one month in active tDCS group with sham tDCS group
total Food intake
measured by logbook for number and amount of daily food intake
Insulin sensitivity
Insulin sensitivity measured by HOMA-IR
post-prandial glucose excursion
continuous glucose monitor to record the frequency and amplitude of glucose excursion

Full Information

First Posted
January 31, 2017
Last Updated
November 1, 2022
Sponsor
University at Buffalo
Collaborators
Harvard Medical School (HMS and HSDM)
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1. Study Identification

Unique Protocol Identification Number
NCT05609604
Brief Title
Role of Transcranial Direct Current Stimulation in Appetite and Weight Control
Acronym
TDCS
Official Title
Role of Trans-cranial Direct Current Stimulation in Appetite and Weight Control: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
No trained/ qualified staff available to perform study.
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Harvard Medical School (HMS and HSDM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.
Detailed Description
To compare weight loss over one month in active tDCS group with sham tDCS group. The investigator will measure weight of every participants at the beginning of the study and one month after the last session of tDCS To compare change in insulin sensitivity over one month in active tDCS group with sham tDCS group. The investigator will measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance (HOMA-IR) To compare change in cognitive performance as a response to food over one month in active tDCS group with sham tDCS group. The investigator will evaluate performance in a computerized task that measures executive functions under the presence of food (working memory, inhibitory control and a combination of both). The investigator will assess changes in accuracy and speed in the task under active tDCS versus sham tDCS. To compare change in post-prandial glucose excursion and average meal counts per day. The investigator will use continuous glucose monitor to record the frequency and amplitude of glucose excursion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Appetite Loss
Keywords
TDCS, Obesity, Appetite, Weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
This group will receive 30 minutes of active stimulation from tDCS
Arm Title
sham tDCS
Arm Type
Placebo Comparator
Arm Description
This group will receive 30 minutes of sham (placebo) stimulation from tDCS
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Electric current will be delivered to the pre-frontal cortex for 30 minutes.
Primary Outcome Measure Information:
Title
change in weight
Description
change in weight, measured as a percentage of baseline body weight
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Personality
Description
Personality measured by Big Five inventory personality questionnaire. The result presented on a scale from 1 to 10. IF your score was 10 - it means that your trait is stronger than 97,72%. High score correlates with inventiveness and intellectual curiosity, low score correlates with consistency and curiosity
Time Frame
5 weeks
Title
insulin sensitivity
Description
measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance
Time Frame
5 weeks
Title
Cognitive response to food measured by computer tasks
Description
response to food over one month in active tDCS group with sham tDCS group
Time Frame
5 weeks
Title
total Food intake
Description
measured by logbook for number and amount of daily food intake
Time Frame
5 weeks
Title
Insulin sensitivity
Description
Insulin sensitivity measured by HOMA-IR
Time Frame
5 weeks
Title
post-prandial glucose excursion
Description
continuous glucose monitor to record the frequency and amplitude of glucose excursion
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 to 80 years of age Body mass index > 30 kg/m2 Exclusion Criteria: Current participation in any other concurrent clinical trials or previous participation within 30 days before the screening visit Pregnancy or premenopausal women who are trying to be pregnant Patients who are incompetent to give consent Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery Have taken any of the following medications within the past 3 months: phentermine, naltrexone, bupropion, topiratmate, lorcaserin, phendimetrazine, methamphetamine, benzphetamine, diethylpropion Any contraindication 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. Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, Transcutaneous Electrical Nerve Stimulation unit, ventriculo-peritoneal shunt or any metallic implant on the head.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh Dandona, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
ECMC Ambulatory Center, 3rd Floor
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Role of Transcranial Direct Current Stimulation in Appetite and Weight Control

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