Anorexia Nervosa, Atypical Anorexia Nervosa
Conditions
Keywords
anorexia nervosa, eating disorder, brain training, brain stimulation, fMRI
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.
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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
triple blind
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa Anderson
University of Minnesota
Outcome results
None listed