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Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

Primary Purpose

Active tDCS, Sham tDCS

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active tDCS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Participants will receive 10 sessions of active tDCS + cognitive training.

Participants will receive 10 sessions of sham tDCS + cognitive training.

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Change in Eating Disorder Examination (EDE) Scores from Baseline to End of Treatment
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.

Full Information

First Posted
July 24, 2018
Last Updated
February 28, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03647943
Brief Title
Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa
Official Title
Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 pandemic (residential treatment center closed to visitors)
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active tDCS, Sham tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Participants will receive 10 sessions of active tDCS + cognitive training.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Participants will receive 10 sessions of sham tDCS + cognitive training.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Intervention Description
Sham transcranial direct current stimulation, involving no electrical stimulation will be used in conjunction with cognitive training for 46 minutes.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Title
Change from Baseline to End of Treatment Set-Shifting Task Performance Following 10-session tDCS + Cognitive Training Intervention Protocol.
Description
Changes in cognitive flexibility will be assessed by examining differences between baseline and end of treatment performance on reversal learning task.
Time Frame
Through study completion, an average of 1 year.
Title
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.
Description
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.
Time Frame
Through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Change in Eating Disorder Examination (EDE) Scores from Baseline to End of Treatment
Description
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.
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelvin O Lim, MD, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share Individual Participant Data (IPD) with other researchers.

Learn more about this trial

Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

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