- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405089
tDCS for Impulsivity and Compulsivity in Obesity
Role of Transcranial Direct Current Stimulation to Decrease Impulsivity and Compulsivity in Individuals With Obesity
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
Cognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.
|
Sham Comparator: 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.
|
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in NIH Examiner Flanker Task Reaction Time
Time Frame: Change between baseline and 4 months post-stimulation (timepoint 8/final visit)
|
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
Time Frame: Change between baseline and 4 months post-stimulation (timepoint 8, final visit)
|
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
Time Frame: Change between baseline and 4 months post-stimulation (i.e., timepoint 8/final visit)
|
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
Time Frame: Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: Change between baseline and 4 months post-intervention (i.e., timepoint 8/final visit)
|
Difference in change in weight (pounds) between active tDCS-cognitive training and sham-cognitive training groups (i.e., end of study weight minus baseline weight). A more negative score indicates a better outcome. |
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
Time Frame: Baseline visit
|
Effect of history of a traumatic brain injury (TBI) on impulsive/compulsive eating behavior. A status of either TBI+ (positive for history of TBI) or TBI- (negative for history of TBI) was determined at the baseline visit with the Minnesota Blast Exposure Screening Tool. Impulsive/compulsive eating behavior was defined as the score on the Binge Eating Scale (BES) taken at the baseline visit. Scale range = 0-48. Lower scores indicate less impulsive/compulsive eating behavior (i.e., a better outcome). Calculation details: Average BES scores taken at baseline for TBI-positive participants and TBI-negative participants. |
Baseline visit
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Shalamar Sibley, MD, MPH, Minneapolis VAMC, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4740A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
-
Dr. Najat KhalifaUniversity of NottinghamRecruitingDecision Making | ImpulsivityCanada
-
Federal University of ParaíbaUnknownAutistic Disorders SpectrumBrazil
-
Nova Southeastern UniversityTerminatedHIV | Mild Neurocognitive DisorderUnited States
-
NYU Langone HealthStony Brook UniversityCompleted
-
Mutual de Seguridad Hospital ClinicoRecruitingCognitive Impairment | Traumatic Brain InjuryChile
-
IRCCS Centro San Giovanni di Dio FatebenefratelliAzienda Ospedaliero, Universitaria Pisana; Azienda Ospedaliera Universitaria... and other collaboratorsUnknownStroke, Ischemic | Stroke HemorrhagicItaly
-
D'Or Institute for Research and EducationCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional... and other collaboratorsCompleted
-
Hospital de Clinicas de Porto AlegreUnknownChronic Pain | EndometriosisBrazil
-
Medical University of South CarolinaCompletedChronic Low Back Pain | Opioid Use, UnspecifiedUnited States
-
University of IowaCompleted