N/A
N=31
tDCS for Impulsivity and Compulsivity in Obesity
Impulsivity · Compulsive Overeating · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04405089 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change in NIH Examiner Flanker Task Reaction Time — -0.03; -0.12 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training (Device); Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Minneapolis Veterans Affairs Medical Center
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in NIH Examiner Flanker Task Reaction Time |
-0.03; -0.12 | — |
| PRIMARY Change in NIH Examiner Set Shifting Task Score |
0.46; 0.43 | — |
| PRIMARY Change in NIH Examiner Dot Counting Task Score |
2.88; 0.67 | — |
| PRIMARY Change in NIH Examiner Unstructured Planning Task Score |
64.25; 41 | — |
| SECONDARY Change in Weight |
2.55; -6 | — |
| SECONDARY Effect of History of Traumatic Brain Injury on Impulsive and Compulsive Eating Behavior |
17; 14.94 | — |
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.
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.)
Data sourced from ClinicalTrials.gov (NCT04405089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.