tDCS for Impulsivity and Compulsivity in Obesity

NCT ID: NCT04405089

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2020-06-26

Brief Summary

Even when they know it can improve health, many individuals with loss of control eating struggle when they are trying to make and sustain new health habits for weight loss and maintenance of weight loss. Impulsivity, characterized by lack of foresight and planning and excessive risk taking, and compulsivity, characterized by inability to break old habitual behaviors, may play a role in refractory obesity. The primary objective of this pilot study is to investigate the effect of a novel neuroplasticity based intervention, cognitive training coupled with transcranial direct current stimulation (tDCS), on measures of impulsivity and compulsivity in individuals with obesity.

Detailed Description

Impulsivity and compulsivity are two psychological factors which contribute to addictive behaviors. Impulsivity is characterized by lack of foresight and planning, and excessive risk taking. Impulsivity is a characteristic of poor executive functioning, and reflects deficits in goal-oriented behavior and self-regulation. Compulsivity is characterized by inability to break old habits. Both of these traits may play a role in refractory obesity. Transcranial direct current stimulation (tDCS) coupled with cognitive training may strengthen key circuitry involved in impulse control within the prefrontal cortex. tDCS coupled with cognitive training has the potential to reduce impulsivity and compulsivity in individuals with obesity, with the potential for therapeutic application as a non-pharmacologic approach to management of food-related eating behaviors which may impact weight.

For this double-blind, randomized, placebo (sham) controlled study pilot study the investigators aim to recruit and complete studies in approximately 20 individuals, randomly assigned to receive either active or sham tDCS, both coupled with computerized cognitive training tasks, for five days. Additionally, participants will attend follow up visits at approximately 2, and 4 months after the course of intervention visits is completed. Testing pre- and post-intervention will include the Binge Eating Scale (BES), Patient Health Questionnaire 9 (PHQ-9) Depression Screen, and 4 domains of the NIH Examiner Battery. Weight will be tracked throughout the study. The Minnesota Blast Exposure Screening Tool (MN-BEST) is also conducted at baseline.

Conditions

Impulsivity; Compulsive Overeating; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS with cognitive training

Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over right frontal cortex, cathode over left frontal cortex; 2 mAmps for 26 minutes).

Group Type: EXPERIMENTAL

Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training

Intervention Type: DEVICE

Cognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.

Sham tDCS with cognitive training

Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Group Type: SHAM_COMPARATOR

Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training

Intervention Type: DEVICE

Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).

Interventions

Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training

Cognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.

Intervention Type: DEVICE

Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training

Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Obese (BMI>30)
• Adults ages 18 years or older receiving care through the Minneapolis VA Healthcare System
• Able to understand English, self-consent and follow study-related procedures
• Willing to use a reliable form of birth control if they are of females of child-bearing potential.

Exclusion Criteria

• History of any of the following issues: seizures, severe or moderate head injury, head surgery, significant neurological disorder(significance based on Principal Investigator's judgment), frequent severe headaches
• History of scalp conditions such as eczema or seborrheic dermatitis
• Metal in head (other than in mouth) including shrapnel/surgical clips/welding fragments
• Implanted medical devices (including pumps and cardiac pacemakers)
• Pregnancy
• Active substance abuse
• Psychological or medical disorders requiring inpatient treatment
• Presence of a known metabolic or hormonal disorder (such as Cushing's) which affects weight/appetite. (History of hypothyroidism is acceptable if subject is on treatment with normal thyroid stimulating hormone (TSH) and free thyroxine (FT4) on most recent check within the last 3 months and has been on stable dosage of l-thyroxine for at least 3 months, taking it as prescribed.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Veterans Research and Education

OTHER

Sponsor Role: collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Shalamar Sibley, MD, MPH

Associate Professor of Medicine, University of Minnesota; Minneapolis VAMC Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shalamar Sibley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VAMC, University of Minnesota

Locations

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

4740A

Identifier Type: -

Identifier Source: org_study_id