tDCS and Cognitive Training for Restrictive Eating Disorders

NCT06624150 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: PSYCH-2022-31551
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Atypical Anorexia Nervosa

Keywords

anorexia nervosa; eating disorder; brain training; brain stimulation; fMRI

Outcome Measures

Primary Outcomes (4)

• the rate of dropout.

  Feasibility and tolerability measure 1. Evaluating for less than 20% dropout over the course of the tDCS for R-EDs study.

  14 days average

• Number of participants retained in the tDCS

  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).

  14 days average

• probabilistic reversal learning task

  Change from pre intervention to post intervention scores in probabilistic reversal learning task performance

  14 days average

• Dimensional set shifting task

  change from pre to post intervention scores in dimensional set shifting task.

  14 days average

Study Arms (2)

Active tDCS

EXPERIMENTAL

10 Active tDCS sessions: 10 active sessions of transcranial direct current stimulation paired with cognitive training tasks. Device used is StarStim.

Device: Active tDCS sessions, StarStim device

Sham (fake) tDCS

SHAM COMPARATOR

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.

Device: Sham (fake) tDCS sessions

Interventions

Active tDCS sessions, StarStim device DEVICE

10 active sessions of transcranial direct current stimulation paired with cognitive training tasks. Device used is StarStim.

Active tDCS

Sham (fake) tDCS sessions DEVICE

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.

Sham (fake) tDCS

Eligibility Criteria

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

You may qualify if:

• 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)

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 (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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Anderson

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Day

CONTACT

612-625-1542; [email protected]

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple blind
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot mechanistic trial examining cognitive training and brain stimulation effects on cognitive performance. Participants are randomly assigned to active or sham (fake) brain stimulation conditions.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: October 2, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

US (1)