tDCS for Impulsivity and Compulsivity in Obesity

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status: Completed

Conditions: Compulsive Overeating; Obesity; Impulsivity

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04405089

4740A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups

Active tDCS with cognitive training

Experimental group

Description:

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).

Treatment:

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

Sham tDCS with cognitive training

Sham Comparator group

Description:

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.

Treatment:

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