Clinical trial NCT04405089: tDCS for Impulsivity and Compulsivity in Obesity
Official title: Role of Transcranial Direct Current Stimulation to Decrease Impulsivity and Compulsivity in Individuals With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impulsivity
Compulsive Overeating
Obesity
Keywords: Impulsive Behavior
Behavior Control
Appetitive Behavior
Health Risk Behaviors
Compulsive Behavior
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Center for Veterans Research and Education
First posted: 2020-05-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is not a disease treatment study. It involves of an Non-Significant Risk (NSR) device coupled with a set of computerized cognitive tasks in a small group of participants with primary outcome of change in an NIH Examiner domain (Flanker).
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Change in NIH Examiner Flanker Task Reaction Time
timeFrame: Change between baseline and 4 months post-stimulation (timepoint 8/final visit)
measure: Change in NIH Examiner Set Shifting Task Score
timeFrame: Change between baseline and 4 months post-stimulation (timepoint 8, final visit)
measure: Change in NIH Examiner Dot Counting Task Score
timeFrame: Change between baseline and 4 months post-stimulation (i.e., timepoint 8/final visit)
measure: Change in NIH Examiner Unstructured Planning Task Score
timeFrame: Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit)
Secondary outcomes:
measure: Change in Weight
timeFrame: Change between baseline and 4 months post-intervention (i.e., timepoint 8/final visit)
measure: Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior
timeFrame: Baseline visit
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis VAMC, University of Minnesota
name: Shalamar Sibley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: