Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

NCT ID: NCT03647943

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active tDCS

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

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: 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.

Sham tDCS

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

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelvin O Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

PSYCH-2018-26509

Identifier Type: -

Identifier Source: org_study_id