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Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT03647943
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of the study is to evaluate the use of a new brain stimulation tool called transcranial direct current stimulation (tDCS). tDCS is a new technique used to stimulate the brain. The investigators believe that it may help to change brain function in individuals with anorexia nervosa. The brain stimulation occurs outside the head. The tDCS procedure involves applying a small amount of electrical current across the scalp, for a short period of time. This small electrical current is able to change the electrical activity inside areas of the brain. In the current study, the investigators will ask participants to complete computer-based brain training sessions. While participants do the brain training exercises, they will receive either real tDCS for "sham" tDCS. "Sham" tDCS means that participants might feel sensations like tingling or vibrations from the tDCS machine, but will not actually receive the electrical current. Investigators will also ask participants to complete several tests to assess changes in brain function. The information gained from this study will help investigators to understand how tDCS could be used to improve brain function and learning in individuals with anorexia nervosa.

Condition or disease Intervention/treatment Phase
Active tDCS Sham tDCS Device: Transcranial direct current stimulation Device: Sham transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18+ years
  • Documented enrollment in residential-level treatment at The Emily Program and meeting criteria for AN (BMI <18.5).
  • Participant must be capable of giving informed consent, based on University of California San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC)39 risk assessment, which has been uploaded to ETHOS.
  • Sufficient spoken English so as to be able to comprehend testing procedures.

Exclusion Criteria:

  • Substance abuse in the participant
  • Neurological condition or other developmental disorder
  • Serious psychiatric disorder known to affect brain functioning and cognitive performance
  • Medical instability, which will be evident based on required admittance status in the residential treatment facility from which participants will be recruited. (The Emily Program residential treatment patients are followed closely by a medical provider, who routinely assesses medical stability throughout the duration of each patient's stay in the treatment facility; therefore, if a participant is not currently a patient in this setting and/or has been recently discharged from residential treatment setting due to medical need to receive higher level of care/inpatient-level care, they will be excluded from enrollment in this study).
  • MRI contraindication [based on Center for Magnetic Resonance Research (CMRR) prescreening protocol]
  • tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).

Information from the National Library of Medicine

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


Contacts
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Contact: Lisa M Anderson, PhD (612) 273-9743 ande8936@umn.edu
Contact: Kelvin O Lim, MD, PhD (612) 273-9779 kolim@umn.edu

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Kelvin O Lim, MD, PhD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03647943     History of Changes
Other Study ID Numbers: STUDY00002867
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share Individual Participant Data (IPD) with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders