Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

NCT03647943 | Withdrawn

• 1 other identifier: PSYCH-2018-26509
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Active tDCS; Sham tDCS

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

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

  Through study completion, an average of 1 year.

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

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

Device: Sham transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

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.

Active tDCS

Sham transcranial direct current stimulation DEVICE

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

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kelvin O Lim, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One arm of this study is a sham condition; both tDCS and sham tDCS conditions are blinded to participants and study assessor/s.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 27, 2018
• Study Start: August 30, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)