ImpulsivityNCT04405089
tDCS for Impulsivity and Compulsivity in Obesity
A study testing Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training in people with Impulsivity and Compulsive Overeating, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impulsivity, Compulsive Overeating, Obesity
- What is being tested?
- Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 26 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
About this study
Official title: Role of Transcranial Direct Current Stimulation to Decrease Impulsivity and Compulsivity in Individuals With Obesity
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.
Read the 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.
- Conditions
- Impulsivity, Compulsive Overeating, Obesity
- Being tested
- Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training, Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training
- Keywords
- Impulsive Behavior, Behavior Control, Appetitive Behavior, Health Risk Behaviors, Compulsive Behavior
- Medical subject headings
- Impulsive Behavior, Obesity, Appetitive Behavior, Health Risk Behaviors, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive trainingDevice
Cognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.
Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive trainingDevice
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
Measured: 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.
Measured: Change between baseline and 4 months post-stimulation (i.e., timepoint 8, final visit)
Secondary outcomes (2)
Change in Weight
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.
Measured: 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
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.
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start3 May 2018
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ImpulsivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Center for Veterans Research and Education
- Responsible party
- Principal investigator, Shalamar Sibley, MD, MPH, Minneapolis Veterans Affairs Medical Center
- Investigators
- Shalamar Sibley, MD, MPH, Principal investigator, Minneapolis VAMC, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405089
- Sponsor's protocol ID
- 4740A
- Status last verified
- Nov 2023
- First submitted
- 17 May 2020
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transcranial Direct Current Stimulation to Decrease Impulsivity and Compulsivity in Individuals With Obesity
- ClinicalTrials.gov ID
- NCT04405089
- Acronym / sponsor ID
- 4740A
- Conditions
- Impulsivity, Compulsive Overeating, Obesity
- Keywords
- Impulsive Behavior, Behavior Control, Appetitive Behavior, Health Risk Behaviors, Compulsive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Center for Veterans Research and Education
- Study start
- 3 May 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Active tDCS with cognitive training | Experimental | Device: Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive trainingParticipants 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). |
| Sham tDCS with cognitive training | Sham comparator | Device: Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive trainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive trainingCognitive training concurrent with 2 milliamperes (mAmps) of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes. | Device | Active tDCS with cognitive training |
| Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive trainingCognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session). | Device | Sham tDCS with cognitive training |
Primary outcome
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 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 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 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.
2 secondary outcomes
Change in Weight
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalamar Sibley, MD, MPH principal investigator
Minneapolis VAMC, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training in people with Impulsivity and Compulsive Overeating, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIH Examiner Flanker Task Reaction Time (time frame: Change between baseline and 4 months post-stimulation (timepoint 8/final visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.