Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

Sham tDCS Clinical Trial

Official title:

Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03647943
• Other study ID #: PSYCH-2018-26509
• Status: Withdrawn
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Active tDCS
• Anorexia
• Anorexia Nervosa
• Sham tDCS

Intervention

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 transcranial direct current stimulation
Sham transcranial direct current stimulation, involving no electrical stimulation will be used in conjunction with cognitive training for 46 minutes.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 1 year.
Primary	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.	Through study completion, an average of 1 year.
Primary	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.	Through study completion, an average of 1 year.
Secondary	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.	Through study completion, an average of 1 year.