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Clinical study on magnetic resonance guided transcranial focused ultrasound for the treatment of refractory psychiatric disorders with anterior limb destruction of the internal capsule

Clinical study on magnetic resonance guided transcranial focused ultrasound for the treatment of refractory psychiatric disorders with anterior limb destruction of the internal capsule

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107799
Enrollment
Unknown
Registered
2025-08-19
Start date
2025-05-28
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Obsessive-compulsive disorder, anorexia nervosa, Major Depressive Disorder

Interventions

Treatment group:Focused Ultrasound

Sponsors

Beijing GoBroad Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Obsessive-compulsive disorder: (1) The subjects have fully understood the possible risks and benefits of participating in this study and signed the informed consent form; (2) Meet the ICD-11 diagnostic criteria for obsessive-compulsive disorder, with a duration greater than or equal to 5 years (Global Functional Assessment Scale score of -50; The minimum score for Y-BOCS is 28); (3) Meet the diagnostic criteria of refractory obsessive-compulsive disorder in the Chinese Guidelines for the Prevention and Treatment of Obsessive-Compulsive Disorder (2016): at least 3 anti-compulsive drugs are treated in sufficient doses and with a full course of treatment and continue to be treated for more than 12 weeks, combined with at least 2 atypical antipsychotics as synergists, and at least 12 times of cognitive behavioral therapy, and all of the above treatments have no obvious effect, that is, patients with a Y-BOCS reduction rate of 0.45, and no intrafrontal bone hyperplasia; (7) There were no structural abnormalities near bilateral ALIC; (8) Able to tolerate surgery under head frame, awake sedation for about 3 hours, and scalp pain that may occur during ultrasound treatment. 2. Anorexia nervosa: (1) The subjects have fully understood the possible risks and benefits of participating in this study and signed the informed consent form; (2) Meet the ICD-11 diagnostic criteria for anorexia nervosa; (3) Course of the disease> = 3 years; (4) Resistance to the combination of drug treatment and psychotherapy (drug treatment requires at least 2 antidepressants or antipsychotics to be used, and sufficient course of treatment; Psychotherapy needs to be standardized by a psychologist with experience in psychotherapy in a psychiatric department or psychiatric hospital); (5) treatment decisions require the consent of two independent psychiatrists and the attending surgeon; (6) Age 18~60 years old, gender is not limited; (7) Cranial bone density ratio (SDR) > 0.45, and no intrafrontal bone hyperplasia; (8) There were no structural abnormalities near bilateral ALIC; (9) Able to tolerate surgery under head frame, awake sedation for about 3 hours, and scalp pain that may occur during ultrasound treatment. 3. Depression: (1) The subjects have fully understood the possible risks and benefits of participating in this study and signed the informed consent form; (2) Meet the diagnostic criteria for major depression: HAMD>=17 points or Montgomery and Eisenberg Depression Rating Scale (MADRS) >=22 points; or have very serious, uncontrollable suicidal behavior; (3) Poor response to at least 3 antidepressants with appropriate doses and courses of treatment (at least 2 of the 3 drugs have different chemical structures); (4) The course of the disease is more than 3 years; (5) treatment decisions require the consent of two independent psychiatrists and the attending surgeon; (6) Age 18~60 years old, gender is not limited; (7) Cranial bone density ratio (SDR) > 0.45, and no intrafrontal bone hyperplasia; (8) There were no structural abnormalities near bilateral ALIC.

Exclusion criteria

Exclusion criteria: 1. Obsessive-compulsive disorder: (1) Patients with obsessive-compulsive disorder who currently or have suffered from psychosis, bipolar disorder, or severe cognitive impairment; (2) Patients cannot cooperate with the completion of at least 6 months of clinical efficacy follow-up; (3) Contraindications to MRI examination, such as: non-MRI-compatible metal implanted devices (including pacemakers); Those with metal foreign body implantation or residue in the body; suffering from MRI claustrophobia, etc.; (4) Those whose cranial bone density ratio (SDR) does not meet the treatment requirements (determined by the doctor after calculation by head CT examination before treatment); (5) Patients with abnormal coagulation function or bleeding tendency, including patients with a history of abnormal bleeding, internal bleeding and/or coagulation in the body and those who have received anticoagulation therapy or taken drugs known to increase the risk of bleeding within one month; (6) Those with severe dysfunction of important organs, such as patients with unstable heart disease or severe hypertension and patients with advanced kidney disease or dialysis; (7) Patients with organic lesions in the brain such as cerebrovascular disease or brain tumor; (8) Patients who are unable or unwilling to tolerate the long period of static position required during treatment (patients need to lie on their backs on the treatment bed for about 3 hours during treatment). 2. Anorexia nervosa: (1) Current or former psychosis, bipolar disorder, or severe cognitive impairment; (2) Patients cannot cooperate with the completion of at least 6 months of clinical efficacy follow-up; (3) Contraindications to MRI examination, such as: non-MRI-compatible metal implanted devices (including pacemakers); Those with metal foreign body implantation or residue in the body; suffering from MRI claustrophobia, etc. (4) Those whose cranial bone density ratio (SDR) does not meet the treatment requirements (determined by the doctor after calculation by head CT examination before treatment); (5) Patients with abnormal coagulation function or bleeding tendency, including patients with a history of abnormal bleeding, internal bleeding and/or coagulation in the body and those who have received anticoagulation therapy or taken drugs known to increase the risk of bleeding within one month; (6) Those with severe dysfunction of important organs, such as patients with unstable heart disease or severe hypertension and patients with advanced kidney disease or dialysis; (7) Patients with organic lesions in the brain such as cerebrovascular disease or brain tumor; (8) Patients who are unable or unwilling to tolerate the long period of static position required during treatment (patients need to lie on their backs on the treatment bed for about 3 hours during treatment). 3. Depression: (1) Those who currently or have suffered from mental illness, bipolar disorder, or severe cognitive impairment; (2) Patients cannot cooperate with the completion of at least 6 months of clinical efficacy follow-up; (3) Contraindications to MRI examination, such as: non-MRI-compatible metal implanted devices (including pacemakers); Those with metal foreign body implantation or residue in the body; suffering from MRI claustrophobia, etc.; (4) Those whose cranial bone density ratio (SDR) does not meet the treatment requirements (determined by the doctor after calculating the head CT examination before treatment); (5) Patients

Design outcomes

Primary

MeasureTime frame
Yale-Brown Obsessive Compulsive Scale Score;Hamilton Depression Rating Scale score;BMI;Hamilton Anxiety Scale score;

Secondary

MeasureTime frame
Cognitive function;

Countries

China

Contacts

Public ContactYu Xin

Beijing GoBroad Hospital

yux5@gobroadhealthcare.com+86 13701050134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026