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Efficacy and cognitive function of theta-burst stimulation in treating older adults with depression: a randomized sham controlled trial.

Efficacy and cognitive function of theta-burst stimulation in treating older adults with depression: a randomized sham controlled trial.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121655
Enrollment
Unknown
Registered
2026-04-01
Start date
2025-06-23
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Older adults with depression

Interventions

True Stimulation Group:Bilateral sequential TBS (left iTBS+cTBS), 80% RMT intensity, 5 times per week for 2 weeks (10 sessions)
Sham Stimulation Group:Sham stimulation (coil placed at 90° to the scalp, no effective stimulation), 80% RMT intensity, 5 times per week for 2 weeks (10 sessions)

Sponsors

The Brain Hospital of Guangxi Zhuang Autonomous Region.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Provide informed consent; 2. Meet the diagnostic criteria for depression as outlined in the International Classification of Diseases (ICD-10) Application Manual, including first-episode or recurrent depression, regardless of gender; 3. HRSD-17 total score >= 17 points; 4. Age >= 60 years old, right-handed; 5. Complete clinical records, no antidepressant medication use within the past month; 6. Normal uncorrected or corrected visual acuity in both eyes; 7. Compliance with medical ethics committee requirements.

Exclusion criteria

Exclusion criteria: 1. History of severe physical or brain organic diseases, or history of head trauma; 2. Patients with comorbid conditions such as Alzheimer's disease or glaucoma; 3. History of drug, alcohol, or other psychoactive substance abuse; 4. Individuals with contraindications to rTMS (e.g., history of epilepsy, intracranial implants); 5. Patients with a history of manic episodes or schizophrenia.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale-17 (HDRS-17) Score Reduction Rate and Remission Rate;Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduction Rate and Remission Rate;

Secondary

MeasureTime frame
Neurocognitive Function;Anxiety Symptoms;

Countries

China

Contacts

Public ContactLan Xianjun

The Brain Hospital of Guangxi Zhuang Autonomous Region.

327326353@qq.com+86 151 7772 7971

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026