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The regulatory effect of TMS-EEG/fNIRS (transcranial magnetic stimulation - electroencephalogram / functional near-infrared spectroscopy) multimodal closed-loop stimulation technology on depressive state in patients with colorectal cancer: A prospective, randomized controlled, single-blind, single-center clinical study

The regulatory effect of TMS-EEG/fNIRS (transcranial magnetic stimulation - electroencephalogram / functional near-infrared spectroscopy) multimodal closed-loop stimulation technology on depressive state in patients with colorectal cancer: A prospective, randomized controlled, single-blind, single-center clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119841
Enrollment
Unknown
Registered
2026-03-04
Start date
2026-03-05
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Adjuvant stage IIIb after colorectal cancer surgery

Interventions

Transcranial magnetic stimulation (TMS) treatment group:TMS-EEG/fNIRS (transcranial magnetic stimulation - electroencephalography / functional near-infrared spectroscopy) multimodal closed-loop stimul
False stimulation group:Transcranial magnetic stimulation coil intervention

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.The patient voluntarily joined this study, signed the informed consent form, and had good compliance. 2.Aged 18 and above, no gender restrictions. 3.After histological or cytological confirmation of colorectal adenocarcinoma, and when surgery is feasible; 4.ECOG performance score of 0 to 3; 5.The score of the Hamilton Depression Rating Scale (HAMD) is >= 8 points. 6.There is no unconsciousness disorder, with the ability of autonomous behavior, capable of signing the informed consent form and able to follow the research protocol. 7.The estimated survival period is >= 3 months. 8.Before enrollment, no antidepressants had been taken and no electroconvulsive therapy had been performed.

Exclusion criteria

Exclusion criteria: 1. Anxiety and depression caused by somatic factors, such as cancer pain, as evaluated by the researchers; 2. Those with severe cognitive impairment or active psychosis; 3. Those who have participated in other drug clinical trials within the past four weeks; 4. Those with unhealed head wounds that prevent them from wearing a head ring; 5. Those with high fever or severe infection, cachexia, multiple organ failure, or inability to cooperate; 6. Women who are breastfeeding or pregnant; 7. Other conditions deemed unsuitable for TMS-EEG/fNIRS multimodal closed-loop stimulation by a multidisciplinary team; 8. Those with a history of mania; 9. Those with severe suicidal or self-harming thoughts or behaviors; 10. Those with implanted cardiac pacemakers or metal objects in the brain; 11. Those with a history of epilepsy or cranial surgery.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (HAMD);

Secondary

MeasureTime frame
Symptom Checklist 90 (SCL-90);Pittsburgh Sleep Quality Index (PSQI);Hamilton Anxiety Scale (HAMA);

Countries

China

Contacts

Public ContactGu Yanhong

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

guyanhong@njmu.edu.cn+86 25 6830 6714

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026