Tokyo, June 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061748) titled 'A Study Using Transcranial Magnetic Stimulation Testing to Examine the Brain Excitation and Inhibition in Eating Disorders' on June 2.
Study Type:
Observational
Primary Sponsor:
Institute - Chiba University
Condition:
Condition - Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate alterations in intracortical inhibition and facilitation, which are considered to reflect GABAergic and glutamatergic neural functions, in patients with eating disorders using paired-pulse transcranial magnetic stimulation, and to examine their associations with response inhibition and clinical symptoms.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 16
years-old
=
Gender - Male and Female
Key inclusion criteria - Eligible participants are Japanese individuals who meet the DSM-5-TR diagnostic criteria for an eating disorder, including anorexia nervosa, bulimia nervosa, or binge-eating disorder, and who have visited the Department of Psychiatry at Chiba University Hospital. Due to practical constraints in study implementation, recruitment will primarily focus on patients with anorexia nervosa; however, patients with bulimia nervosa or binge-eating disorder may also be enrolled if they meet the eligibility criteria. Participants must be 16 to 65 years of age at the time of informed consent. Participants may also be recruited through the Internet or posted advertisements; however, eligibility will be assessed at the time of informed consent at the Department of Psychiatry of Chiba University Hospital.
Key exclusion criteria - 1. Individuals with psychiatric disorders that preceded the onset of the eating disorder and may substantially affect the assessment of eating disorder pathology, such as schizophrenia spectrum disorders, bipolar disorder, or alcohol or substance use disorders.
2. Individuals with severe physical illnesses.
3. Individuals with a past or current history of central nervous system disorders, other than the target disease, including epilepsy or head injury associated with loss of consciousness.
4. Individuals with metal objects or devices in the head region, including cochlear implants, ferromagnetic clips, deep brain stimulation devices, or vagus nerve stimulation devices, or those with cardiac pacemakers.
5. Individuals who have not been informed of their diagnosis at the time of obtaining consent.
6. Women who are pregnant, may be pregnant, or are breastfeeding.
7. Individuals whose worsening clinical condition makes it difficult for them to fully understand the study and to decide whether to participate.
8. Individuals judged by the attending physician or study physician to be unsuitable for participation in the study.
Target Size - 60
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 10 Month 29 Day
Date of IRB - 2025 Year 10 Month 29 Day
Anticipated trial start date - 2026 Year 02 Month 15 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070610
Disclaimer: Curated by HT Syndication.