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

Sponsor
University at Buffalo (Other)
Overall Status
Terminated
CT.gov ID
NCT05609604
Collaborator
Harvard Medical School (HMS and HSDM) (Other)
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Study Details

Study Description

Brief Summary

To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.

Condition or Disease Intervention/Treatment Phase
  • Device: tDCS
N/A

Detailed Description

  1. 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

  2. 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)

  3. 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.

  4. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Role of Trans-cranial Direct Current Stimulation in Appetite and Weight Control: A Prospective Randomized Study
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Oct 25, 2022
Actual Study Completion Date :
Oct 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: active tDCS

This group will receive 30 minutes of active stimulation from tDCS

Device: tDCS
Electric current will be delivered to the pre-frontal cortex for 30 minutes.

Placebo Comparator: sham tDCS

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

Device: tDCS
Electric current will be delivered to the pre-frontal cortex for 30 minutes.

Outcome Measures

Primary Outcome Measures

  1. change in weight [5 weeks]

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

Secondary Outcome Measures

  1. Personality [5 weeks]

    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

  2. insulin sensitivity [5 weeks]

    measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance

  3. Cognitive response to food measured by computer tasks [5 weeks]

    response to food over one month in active tDCS group with sham tDCS group

  4. total Food intake [5 weeks]

    measured by logbook for number and amount of daily food intake

  5. Insulin sensitivity [5 weeks]

    Insulin sensitivity measured by HOMA-IR

  6. post-prandial glucose excursion [5 weeks]

    continuous glucose monitor to record the frequency and amplitude of glucose excursion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ECMC Ambulatory Center, 3rd Floor Buffalo New York United States 14215

Sponsors and Collaborators

  • University at Buffalo
  • Harvard Medical School (HMS and HSDM)

Investigators

  • Principal Investigator: Paresh Dandona, MD, SUNY Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paresh Dandona, SUNY Distinguished Professor, University at Buffalo
ClinicalTrials.gov Identifier:
NCT05609604
Other Study ID Numbers:
  • TDCS Weight Loss
First Posted:
Nov 8, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Paresh Dandona, SUNY Distinguished Professor, University at Buffalo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2022