Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03647943|
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Active tDCS Sham tDCS||Device: Transcranial direct current stimulation Device: Sham transcranial direct current stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||One arm of this study is a sham condition; both tDCS and sham tDCS conditions are blinded to participants and study assessor/s.|
|Official Title:||Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa|
|Estimated Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Active tDCS
Participants will receive 10 sessions of active tDCS + cognitive training.
Device: Transcranial direct current stimulation
Transcranial direct current stimulation, involving low-levels of electrical stimulation applied to the right and left DLPFC will be used in conjunction with cognitive training for 46 minutes.
Sham Comparator: Sham tDCS
Participants will receive 10 sessions of sham tDCS + cognitive training.
Device: Sham transcranial direct current stimulation
Sham transcranial direct current stimulation, involving no electrical stimulation will be used in conjunction with cognitive training for 46 minutes.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and rate of treatment dropout in treatment-seeking adults with AN receiving treatment in a residential treatment program for eating disorders. [ Time Frame: Through study completion, an average of 1 year. ]Treatment-related adverse events will be assessed by CTCAE v4.0 criteria. Participant dropout will be examined in effort to evaluate whether individuals with AN will tolerate the procedures and remain in the study. This will be evinced by less than 20% dropout over the course of active tDCS and cognitive training.
- Change from Baseline to End of Treatment Set-Shifting Task Performance Following 10-session tDCS + Cognitive Training Intervention Protocol. [ Time Frame: Through study completion, an average of 1 year. ]Changes in cognitive flexibility will be assessed by examining differences between baseline and end of treatment performance on reversal learning task.
- Change from Baseline to End of Treatment Resting State and Task-based Functional Magnetic Resonance Imaging (fMRI) Activation during Reversal Learning Task Following 10-session tDCS + Cognitive Training Intervention Protocol. [ Time Frame: Through study completion, an average of 1 year. ]Changes in brain circuitry assessed during resting state and task-based fMRI will be assessed to examine whether active tDCS is associated with greater change in associated circuitry, as compared with sham tDCS.
- Change in Eating Disorder Examination (EDE) Scores from Baseline to End of Treatment [ Time Frame: Through study completion, an average of 1 year. ]Change in eating disorder psychopathology, measured by the EDE, will be evaluated over the course of a 10-session tDCS + cognitive training intervention to determine whether tDCS is associated with significant change in eating pathology among individuals with Anorexia Nervosa.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647943
|Contact: Lisa M Anderson, PhD||(612) firstname.lastname@example.org|
|Contact: Kelvin O Lim, MD, PhD||(612) email@example.com|
|Principal Investigator:||Kelvin O Lim, MD, PhD||University of Minnesota - Clinical and Translational Science Institute|