tDCS for Impulsivity and Compulsivity in Obesity

NCT04405089 | Completed Results FDA Device

• 1 other identifier: 4740A
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Impulsivity; Compulsive Overeating; Obesity

Keywords

Impulsive Behavior; Behavior Control; Appetitive Behavior; Health Risk Behaviors; Compulsive Behavior

Outcome Measures

Primary Outcomes (4)

• Change in NIH Examiner Flanker Task Reaction Time

  Differences in change in Flanker Task reaction time (score at final follow-up visit minus score at baseline) between active tDCS-cognitive training and sham-cognitive training groups. NIH Flanker absolute value range: 0 to 5 seconds. Higher values represent a better outcome. In the Flanker Task, a participant is instructed to press a key in response to viewing a stimulus presented on-screen. The Reaction Time, or the amount of time in seconds between presentation of the stimulus and the response, is measured.

  Change between baseline and 4 months post-stimulation (timepoint 8/final visit)

• Change in NIH Examiner Set Shifting Task Score

  Difference in change in Set Shifting Task scores (score at final visit minus baseline score) between active tDCS-cognitive training and sham- Higher values represent a better outcome. Set Shifting Scale absolute value range: Minimum -10, Maximum 10. The Set Shifting Task Score is a combination of two subscores for reaction time and accuracy on the task.

  Change between baseline and 4 months post-stimulation (timepoint 8, final visit)

• Change in NIH Examiner Dot Counting Task Score

  Differences in change in NIH Examiner Dot Counting Task scores (i.e., score at final visit minus baseline score) between active tDCS-cognitive training and sham-cognitive training groups. The change in score is equal to the score taken at the final follow-up visit minus the score taken at baseline. NIH Dot Counting absolute value range: numerical value -27 to +27. Higher values represent a better outcome. The Dot Count Task Score is the total sum of points awarded for dots a participant counts on the screen. The total score is a sum of scores for 27 individual trials.

  Change between baseline and 4 months post-stimulation (i.e., timepoint 8/final visit)

• Change in NIH Examiner Unstructured Planning Task Score

  Differences in change in NIH Examiner Unstructured Planning Task scores (i.e., score at final visit minus baseline score) between active tDCS-cognitive training and sham-cognitive training groups. The change in score is equal to the score taken at the final follow-up visit minus the score taken at baseline. Higher values represent a better outcome. The Unstructured Task Score is a numeric summary score that is equal to the total sum of points awarded for completed puzzle items. The total absolute score is a sum of scores for 3 individual trials, Absolute score range :-1469 to +1469.

  Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit)

Secondary Outcomes (2)

• Change in Weight

  Change between baseline and 4 months post-intervention (i.e., timepoint 8/final visit)

• Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior

  Baseline visit

Study Arms (2)

Active tDCS with cognitive training

EXPERIMENTAL

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).

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

Sham tDCS with cognitive training

SHAM COMPARATOR

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.

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

Interventions

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

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

Active tDCS with cognitive training

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

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

Sham tDCS with cognitive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead
• Center for Veterans Research and Education: collaborator

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Impulsive Behavior; Obesity; Appetitive Behavior; Health Risk Behaviors; Compulsive Behavior

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Health Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Our study was a pilot feasibility study.

Results Point of Contact

• Title: Dr. Shalamar Sibley, MD, MPH
• Organization: Minneapolis VA Medical Center

Shalamar.Sibley@va.gov

612-467-1727

Study Officials

• Shalamar Sibley, MD, MPH

  Minneapolis VAMC, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, University of Minnesota; Minneapolis VAMC Staff Physician

Model Details: 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).

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 28, 2020
• Study Start: May 3, 2018
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-11

Locations

US (1)