Clinical trial NCT06624150: tDCS and Cognitive Training for Restrictive Eating Disorders
Official title: tDCS and Cognitive Training for Restrictive Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Anorexia Nervosa
Atypical Anorexia Nervosa
Keywords: anorexia nervosa
eating disorder
brain training
brain stimulation
fMRI
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: the rate of dropout.
timeFrame: 14 days average
measure: Number of participants retained in the tDCS
timeFrame: 14 days average
measure: probabilistic reversal learning task
timeFrame: 14 days average
measure: Dimensional set shifting task
timeFrame: 14 days average
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lisa Anderson
role: PRINCIPAL_INVESTIGATOR
References: