NIPH Clinical Trials Search

Intermittent Theta Burst Stimulation for Eating Disorders with Self-Induced Vomiting: A Double-Blind Trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	anorexia nervosa binge-eating/purging type; ANBP bulimia nerbosa; BN
Date of first enrollment	30/04/2025
Target sample size	54
Countries of recruitment
Study type	Interventional
Intervention(s)	intermittent theta burst stimulation

Outcome(s)

Primary Outcome

Frequency of binge eating and vomiting episodes per week

Secondary Outcome

<Clinical Evaluation Parameters> Evaluation of blood test parameters before and after iTBS treatment, including neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, monocyte/lymphocyte ratio, amylase, S-type amylase, P-type amylase, thyroid-stimulating hormone (TSH), Free-T3, Free-T4, AST, ALT, and selenium. Scores on various scales (EDE-Q, BITE, PHQ-9) before and after iTBS treatment. <Neuroimaging Evaluation Parameters> Neural networks measured by resting-state fMRI before and after iTBS treatment. Neuromelanin in the substantia nigra measured by neuromelanin imaging before iTBS treatment. Volume and structure of brain regions involved in the dopamine neural circuitry before iTBS treatment. <Cognitive Function Evaluation Parameters> Scores on the RSVP task before and after iTBS treatment. <Safety Evaluation Parameters> Headache, pain at the stimulation site, discomfort at the stimulation site, muscle contraction, episodes of mania/hypomania (meeting the diagnostic criteria of DSM-5-TR), suicidal ideation, presence of seizures.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	(1) Age: Participants aged 18 years and older (2) Diagnosis: Diagnosed by two certified psychiatrists with ANBP (Anorexia Nervosa Binge-Eating/Purging Type) or BN (Bulimia Nervosa) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) criteria (3) Duration of Illness: From 3 years since onset (4) Weight: A Body Mass Index (BMI) of 14 kg/m2 or above (5) Complications: No need for physical management such as intravenous drips or nasogastric tube feeding (6) Symptoms: Exhibits binge eating and self-induced vomiting at least twice a week (7) Pharmacotherapy: No change in psychotropic medication in the 4 weeks prior to the iTBS (intermittent Theta Burst Stimulation) implementation (8) Consent Acquisition: Informed consent obtained from the participants for their involvement in this study.
Exclude criteria	1. Patients with substance use disorders 2. Patients with psychotic disorders 3. Patients with organic mental disorders 4. Patients with a history of epilepsy or seizure attacks 5. Patients with intracranial lesions that pose a risk of seizure attacks 6. Patients currently taking medication that lowers the seizure threshold (such as methylphenidate, zotepine, or maprotiline) 7. Patients with severe complications, including liver disorders, renal disorders, heart diseases, pulmonary diseases, hematologic diseases, or metabolic diseases 8. Patients with cardiac pacemakers 9. Patients with metal objects near the stimulation site (such as cochlear implants, magnetic body clips, or devices for deep brain stimulation or vagus nerve stimulation) 10. Patients with non-proximate metal objects, cranial titanium products, or magnetically attached dentures/implants, making MRI imaging difficult 11. Pregnant women, those who may be pregnant, or those wishing to become pregnant during the trial period 12. Patients who have previously received TMS therapy 13. Patients undergoing cognitive behavioral therapy