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tDCS for Impulsivity and Compulsivity in Obesity

Primary Purpose

Impulsivity, Compulsive Overeating, Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impulsivity focused on measuring Impulsive Behavior, Behavior Control, Appetitive Behavior, Health Risk Behaviors, Compulsive Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.)

Sites / Locations

  • Minneapolis VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS with cognitive training

Sham tDCS with cognitive training

Arm 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).

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.

Outcomes

Primary Outcome Measures

Change in NIH Examiner Flanker Score
Differences in magnitude of changes in Flanker scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
Change in NIH Examiner Set Shifting Score
Differences in magnitude of changes in Set Shifting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
Change in NIH Examiner Dot Counting Score
Differences in magnitude of changes in Dot Counting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
Change in NIH Examiner Unstructured Planning Task Score
Differences in magnitude of changes in Unstructured Planning Task scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions

Secondary Outcome Measures

Change in weight
Differences in magnitude of changes in weight (pounds) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-Binge Scale
Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Binge Eating Scale Scores (numeric summary score) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Flanker
Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Flanker scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Set Shifting
Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST) , on differences in magnitude of changes on Set Shifting scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study

Full Information

First Posted
May 17, 2020
Last Updated
May 26, 2020
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Center for Veterans Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT04405089
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
June 5, 2020 (Anticipated)
Study Completion Date
June 5, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Center for Veterans Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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), PHQ-9 Depression Screen, and 4 domains of the NIH Examiner Battery. Weight will be tracked throughout the study. MN-BEST blast exposure screening tool is also conducted at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsivity, Compulsive Overeating, Obesity
Keywords
Impulsive Behavior, Behavior Control, Appetitive Behavior, Health Risk Behaviors, Compulsive Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS with cognitive training
Arm Type
Experimental
Arm 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).
Arm Title
Sham tDCS with cognitive training
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
Intervention Description
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.
Intervention Type
Device
Intervention Name(s)
Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
Intervention Description
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Primary Outcome Measure Information:
Title
Change in NIH Examiner Flanker Score
Description
Differences in magnitude of changes in Flanker scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
Time Frame
Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
Title
Change in NIH Examiner Set Shifting Score
Description
Differences in magnitude of changes in Set Shifting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
Time Frame
Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
Title
Change in NIH Examiner Dot Counting Score
Description
Differences in magnitude of changes in Dot Counting scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
Time Frame
Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
Title
Change in NIH Examiner Unstructured Planning Task Score
Description
Differences in magnitude of changes in Unstructured Planning Task scores (numeric summary scores) between active tDCS-cognitive training and sham-cognitive training groups from baseline to follow-up sessions
Time Frame
Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
Secondary Outcome Measure Information:
Title
Change in weight
Description
Differences in magnitude of changes in weight (pounds) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
Time Frame
Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
Title
Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-Binge Scale
Description
Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Binge Eating Scale Scores (numeric summary score) between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
Time Frame
Change between baseline and 4 months post intervention
Title
Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Flanker
Description
Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST), on differences in magnitude of changes in Flanker scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
Time Frame
Change between baseline and 1 week follow-up, and 2, and 4 months post intervention
Title
Effect of history of traumatic brain injury on impulsive and compulsive eating behavior-NIH Set Shifting
Description
Effect of traumatic brain injury history at baseline (none, single, multiple prior episodes), as measured with Minnesota Blast Exposure Screening Tool (MN-BEST) , on differences in magnitude of changes on Set Shifting scores between active tDCS-cognitive training and sham-cognitive training groups from baseline to end of study
Time Frame
Change between baseline and 1 week follow-up, and 2, and 4 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalamar Sibley, MD, MPH
Organizational Affiliation
Minneapolis VAMC, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

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tDCS for Impulsivity and Compulsivity in Obesity

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