RecruitingPhase 1NCT06624150

tDCS and Cognitive Training for Restrictive Eating Disorders


Sponsor

University of Minnesota

Enrollment

20 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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)

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Interventions

DEVICEActive tDCS sessions, StarStim device

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

DEVICESham (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.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT06624150


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