tDCS and Cognitive Training for Restrictive Eating Disorders

Phase 1

Recruiting

• Conditions: Anorexia Nervosa; Atypical Anorexia Nervosa
• Interventions: Device: Active tDCS sessions, StarStim device; Device: Sham (fake) tDCS sessions

• Registration Number: NCT06624150
• Lead Sponsor: University of Minnesota

Brief Summary

This study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tDCS) can enhance brain training. Participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-19
• Study Start: 2024-08-02
• Status Verified: 2024-09
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-08-02
• Study Completion: 2026-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 18-65 years
• Self-reported enrollment in outpatient-level treatment at local eating disorder treatment centers in the Twin Cities region, and meeting DSM-5 criteria for AN (mild severity, based on BMI greater than or equal to 17.0 kg/m2) or atypical AN diagnosis (based on MINI and EDE assessments).
• Participant must be capable of giving informed consent, based on UCSD Brief Assessment of Capacity to Consent (UBACC) risk assessment.
• Sufficient spoken English so as to be able to comprehend testing procedures. Normative ranges on a C-RENAL blood panel (panel and ranges specified here: https://labguide.fairview.org/showtest.asp?testid=3321)

Exclusion Criteria

• Substance abuse in the participant
• Neurological condition or other developmental disorder
• Serious psychiatric disorder known to affect brain functioning and cognitive performance (e.g., schizophrenia, schizoaffective disorder)
• Medical instability, which will be evident based on required outpatient treatment status. In standard eating disorders treatment, individuals who are not medically stable are referred to higher levels of care (e.g., residential treatment, inpatient). Therefore, if a participant is enrolled in higher level care for their eating disorder diagnosis, this indicates medical instability and they will be excluded from enrollment in this study.
• tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
• Acute suicidality (suicidalideation with a plan or intent), assessed via MINI suicidality module and Beck Depression Inventory suicide item
• Acute homicidality (homicidal ideation with a plan or intent), assessed via MINI
• Moderate, severe or extreme AN diagnostic severity, based on BMI as per DSM-5 criteria (e.g., BMI <17.0 kg/m2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active tDCS	Active tDCS sessions, StarStim device	10 Active tDCS sessions: 10 active sessions of transcranial direct current stimulation paired with cognitive training tasks. Device used is StarStim.
Sham (fake) tDCS	Sham (fake) tDCS sessions	10 Sham (fake) tDCS sessions: 10 fake sessions of transcranial direct current stimulation paired with cognitive training tasks. The device will be on the participants head, but the current will not be active.

Primary Outcome Measures

Name	Time	Method
the rate of dropout.	14 days average	Feasibility and tolerability measure 1. Evaluating for less than 20% dropout over the course of the tDCS for R-EDs study.
Number of participants retained in the tDCS	14 days average	Feasibility and tolerability measure 2 . # of participants retained in the tDCS and cognitive training space of the study (80% or more retention will be used as the assessment threshold).
probabilistic reversal learning task	14 days average	Change from pre intervention to post intervention scores in probabilistic reversal learning task performance
Dimensional set shifting task	14 days average	change from pre to post intervention scores in dimensional set shifting task.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States