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A prospective, double-blind, randomized, controlled trial of rTMS on depression and quality of life in adolescent idiopathic scoliosis patients treated with brace

A prospective, double-blind, randomized, controlled trial of rTMS on depression and quality of life in adolescent idiopathic scoliosis patients treated with brace

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099455
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Idiopathic scoliosis

Interventions

Experimental Group:rTMS true stimulation and conventional psychological counseling.
Control Group:rTMS sham stimulation combined with conventional psychological counseling.

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.The patient was diagnosed with adolescent idiopathic scoliosis; 2.Age 10-18 years old; 3.Risser index 0-2; 4.Cobb Angle 20-40; 5.orthosis treatment, wearing orthosis for more than 3 months, wearing time more than 12 hours per day, and never undergoing surgical treatment; 6.Depressive disorder meets the diagnostic criteria of ICD-10; 7.Patients with mild to moderate depression (HAMD scale (24 items) scores of 8-35); 8.Stable vital signs and able to complete the study protocol; 9.Had never taken antidepressant drugs; 10.Informed consent was signed by the participants and their guardians;

Exclusion criteria

Exclusion criteria: 1.Any lifelong mental disorder, intellectual disability, substance dependence or abuse (other than nicotine and caffeine, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder or eating disorder) within the past year; 2.Metal or electronic implants (e.g., pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, ventriculoperitoneal shunt internal fixation devices, etc.); 3.Any history of neurological disease or epilepsy; 4.Unstable physical condition; 5.Contraindications of rTMS and fNIRS, including large skull defect, restlessness, alcohol abuse, etc; 6.Other serious diseases that may affect the study.

Design outcomes

Primary

MeasureTime frame
hamilton depression scale,HAMD-24 score;

Secondary

MeasureTime frame
Scoliosis Research Society-22,SRS-22 score;Brace Questionnaire,BrQ score;Cobb angle;Brace wearing time;Verbal fluency task ,VFT;

Countries

China

Contacts

Public ContactHe Lei

The Third Affiliated Hospital Sun Yat-sen University

helei26@mail.sysu.edu.cn+86 13430356593

Outcome results

None listed

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