tDCS and Cognitive Training for Restrictive Eating Disorders

NCT ID: NCT06624150

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-02

Study Completion Date

2026-06-02

Brief Summary

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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

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Conditions

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Anorexia Nervosa Atypical Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
triple blind

Study Groups

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Active tDCS

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

Group Type EXPERIMENTAL

Active tDCS sessions, StarStim device

Intervention Type DEVICE

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

Sham (fake) tDCS

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.

Group Type SHAM_COMPARATOR

Sham (fake) tDCS sessions

Intervention Type 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.

Interventions

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Active tDCS sessions, StarStim device

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Anderson

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maya Day

Role: CONTACT

612-625-1542

Facility Contacts

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Maya Day

Role: primary

Other Identifiers

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PSYCH-2022-31551

Identifier Type: -

Identifier Source: org_study_id

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