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FNT for Anorexia Nervosa: An Open-Label Study

Accelerated Intermittent Theta Burst Stimulation for Anorexia Nervosa: An Open-Label Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042260043
Enrollment
7
Registered
2026-05-29
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia nervosa Anorexia nervosa

Interventions

Sponsors

Sakuma Kenji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The clinical trial will be described in detail to the individuals, and written informed consent will be obtained from all participants and their guardians 2. Individuals age: 18 >= years old and = 12 and = 10 mg/day in escitalopram equivalents) or antipsychotics (>= 3 mg/day in aripiprazole equivalents) with a sufficient dose for 4 weeks or more (failure to achieve a weight gain of >= 0.5 kg/week during the treatment period). We will confirm the result from their medical records. 6. Individuals who will not respond to inpatient treatment for 4 weeks or more (failure to achieve a weight gain of >= 0.5 kg/week during the treatment period). We will confirm the result from their medical records.

Exclusion criteria

Exclusion criteria: 1. Individuals with metal implants or devices close to the stimulation site (e.g., cochlear implants, surgical clips with magnetic properties, or neurostimulators such as deep brain stimulation or vagus nerve stimulation), individuals with a cardiac pacemaker 2. Individuals with metal implants or devices not close to the stimulation site (e.g., implanted medication pumps), titanium products in their heads, magnetic dentures/implants 3. Individuals with a history of seizures, a history of intracranial lesions at risk for seizures, individuals taking drugs that reduce seizure threshold (methylphenidate or ketamine), individuals with alcohol or stimulant use disorder or withdrawal, pregnant individuals, individuals with severe physical disease 4. Individuals with a history of receiving rTMS in the current depressive episode (with a diagnosis of major depressive disorder within the past 6 months) 5. Individuals in whom low body weight will be judged to be attributable to psychiatric disorders other than anorexia nervosa (including dementia, depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, anxiety disorders, autism spectrum disorder, and borderline personality disorder) or to organic diseases (including endocrine and metabolic disorders, gastrointestinal diseases, infections, and malignancies) 6. Individuals with unimproved low body weight due to poor adherence to pharmacological treatment 7. Individuals diagnosed with substance or medication-induced mood disorder 8. Individuals who will answer "yes" at baseline to the following questions: "Do you have any suicidal ideations although you do not have any plans for committing suicide? or "Do you have any suicidal ideations and any plans for committing suicide?" 9. Individuals judged to be inappropriate by researchers

Design outcomes

Primary

MeasureTime frame
Change in overall psychological symptoms of anorexia nervosa (change from baseline to week 4 in EDI-3 eating disorder risk composite score)

Secondary

MeasureTime frame
1. Change in overall psychological symptoms of anorexia nervosa (change from baseline to day 5-7, week 2, and 6 in EDI-3 eating disorder risk composite score) 2. Change in ineffectiveness (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 ineffectiveness composite score) 3. Change in interpersonal problems (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interpersonal problems composite score) 4. Change in affective problems (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 affective problems composite score) 5. Change in overcontrol (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 overcontrol composite score) 6. Change in psychological maladjustment (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 global psychological maladjustment composite score) 7. Change in drive for thinness (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 drive for thinness subscale score) 8. Change in bulimia (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 bulimia subscale score) 9. Change in body dissatisfaction (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 body dissatisfaction subscale score) 10. Change in low self-esteem (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 low self-esteem subscale score) 11. Change in personal alienation (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 personal alienation subscale score) 12. Change in interpersonal insecurity (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interpersonal insecurity subscale score) 13. Change in interpersonal alienation (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interpersonal alienation subscale score) 14. Change in interoceptive deficits (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interoceptive deficits subscale score) 15. Change in emotional dysregulation (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 emotional dysregulation subscale score) 16.

Contacts

Public ContactKenji Sakuma

Fujita Health University Hospital

sakuma44@fujita-hu.ac.jp+81-562-93-9250

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026