Role of Transcranial Direct Current Stimulation in Appetite and Weight Control

NCT05609604 | Terminated Results FDA Device

• 1 other identifier: TDCS Weight Loss
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Weight Loss; Appetite Loss

Keywords

TDCS; Obesity; Appetite; Weight loss

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

  change in body weight in Kg measured from baseline at 5 weeks

  5 weeks

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

This group will receive 30 minutes of active stimulation from tDCS

Device: tDCS

sham tDCS

PLACEBO COMPARATOR

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

Device: Shame- No current

Interventions

tDCS DEVICE

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

active tDCS

Shame- No current DEVICE

Also known as: No current control arm

sham tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 to 80 years of age
• Body mass index \> 30 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

ECMC Ambulatory Center, 3rd Floor

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Weight Loss; Anorexia; Obesity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Paresh Dandona
• Organization: UBuffalo

ghanim@buffalo.edu

17168818924

Study Officials

• Paresh Dandona, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: November 8, 2022
• Study Start: January 1, 2017
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)