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Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Erectile Dysfunction: A Prospective, Randomized Controlled Trial

Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Erectile Dysfunction: A Prospective, Randomized Controlled Trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124723
Enrollment
Unknown
Registered
2026-05-15
Start date
2026-05-16
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Erectile Dysfunction

Interventions

Control group:The sham stimulation mimics the timing and sound of the active treatment but delivers no meaningful magnetic field.

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for erectile dysfunction (ED), with an International Index of Erectile Function-5 (IIEF-5) score =60% and duration >= 10 minutes; 6.Agree not to use any ED-related treatments during the study period, sign the informed consent form, and accept monthly follow-up and guidance via WeChat, telephone, or outpatient visits.

Exclusion criteria

Exclusion criteria: 1.Abnormal findings on sex hormone testing; 2.Poorly controlled blood pressure or blood glucose, or unstable cardiovascular disease; 3.Congenital malformations or anatomical abnormalities of the genital organs, or anatomical penile deformities including Peyronie's disease; 4.History of any serious medical illness, psychiatric disorder, or neurological disease; 5.History of using medications known to cause sexual dysfunction, or a known medical condition clearly associated with sexual dysfunction; 6.Left-handed patients.

Design outcomes

Primary

MeasureTime frame
International Index of Erectile Function?5 ;Erection Hardness Score;Symptom Checklist 90;

Secondary

MeasureTime frame
Montreal Cognitive Assessment Scale;Hamilton Anxiety Scale;Hamilton Depression Rating Scale;Magnetic Resonance Imaging of the Head;Serological markers;Pittsburgh Sleep Quality Index;

Countries

China

Contacts

Public ContactXiansheng Zhang

The First Affiliated Hospital of Anhui Medical University

xiansheng-zhang@163.com+86 135 1497 1898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026