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

Role of Trans-cranial Direct Current Stimulation in Appetite and Weight Control: A Prospective Randomized Study

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

Study Overview

• Status: Terminated
• Conditions: Weight Loss; Appetite Loss
• Intervention / Treatment: Device: tDCS; Device: Shame- No current

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • ECMC Ambulatory Center, 3rd Floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Shame- No current; Other Names: No current control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	change in body weight in Kg measured from baseline at 5 weeks	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 weeks
insulin sensitivity	measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance	5 weeks
Cognitive response to food measured by computer tasks	response to food over one month in active tDCS group with sham tDCS group	5 weeks
total Food intake	measured by logbook for number and amount of daily food intake	5 weeks
Insulin sensitivity	Insulin sensitivity measured by HOMA-IR	5 weeks
post-prandial glucose excursion	continuous glucose monitor to record the frequency and amplitude of glucose excursion	5 weeks

Collaborators and Investigators

• Sponsor: University at Buffalo
• Collaborators: Harvard Medical School (HMS and HSDM)
• Investigators: Principal Investigator: Paresh Dandona, MD, SUNY Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; Appetite; TDCS
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: TDCS Weight Loss

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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