Effects of electro-acupuncture and MRI-guided rTMS on post-stroke depression

Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD: a fMRI-based Single-center, Randomized, Controlled, Assessor-blinded Trial

This study is testing whether a combination of electro-acupuncture and brain stimulation can help people who are dealing with depression after having a stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05516680 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of electro-acupuncture combined with MRI-navigated repetitive transcranial magnetic stimulation (rTMS) for treating post-stroke depression (PSD). It involves a randomized, controlled design with 64 participants, who will be divided into an experimental group receiving the treatment and a control group. The study aims to assess improvements in depressive symptoms, neuro-patho-physiological behaviors, and overall quality of life, while also exploring the central mechanisms of depression through fMRI. The trial will focus on patients who have experienced their first stroke within the last six months.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 40-75 who have experienced their first stroke within the last six months and meet specific clinical criteria for PSD.

Not a fit: Patients who have received other antidepressant therapies or are involved in other clinical trials within two weeks prior to the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a novel, non-pharmacological option for alleviating symptoms of post-stroke depression.

How similar studies have performed: Previous studies have shown positive effects of electro-acupuncture and rTMS on depression, suggesting potential success for this combined approach.

Eligibility criteria

Inclusion Criteria:

Inclusion criteria for patients:

* Meet the TCM and Western medicine diagnostic criteria for first onset stroke within 6 months;
* Aged 40-75 years;
* Right-handed;
* Single infarct in basal ganglia (volume:3-5cm);
* Motor evoked potential (MEP) could be recorded by bilateral primary motor cortex (M1) stimulating.
* National Institutes of Health Stroke Scale (NIHSS) score \<6;
* Hamilton Depression Scale-24 items (HAMD-24) score \> 8;
* Clear consciousness, no hearing and visual impairment, and cooperative physical examination (Glasgow Coma Scale (GCS) score \> 8);
* Complete the screening, and sign the informed consent form voluntarily.

Inclusion criteria for healthy subjects:

* Healthy subjects, aged 40-75 years;
* Right-handed;
* HAMD-24 score \< 8;
* Sign the informed consent voluntarily.

Exclusion Criteria:

Exclusion criteria for patients:

* Have received other antidepressant therapy or involved in other clinical trials in 2 weeks;
* Infarct was located in the left DLPFC;
* With positive psychiatric history and major trauma exposure history, such as depression, epilepsy, etc. in the past;
* With other serious concomitant diseases (aphasia, severe edema, venous thrombosis, arteriosclerosis occlusion, diabetic vascular disease, peripheral neuropathy, spinal lesions, brain trauma, intracranial infection, brain tumors, etc.), and secondary diseases (heart, liver, renal failure, etc.);
* Infection around acupoints and/or intolerance of acupuncture manipulation;
* With MRI or rTMS contraindications (claustrophobia, metal implants, cochlear implants, impulsator, etc.).

Exclusion criteria for healthy subjects:

* Have involved in other clinical trials in 2 weeks;
* With positive psychiatric history and major trauma exposure history, including depression, epilepsy, etc. in the past;
* With MRI or rTMS contraindications (claustrophobia, metal implants, cochlear implants, impulsator, etc.).

Where this trial is running

Nanjing, Jiangsu

• Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (Recruiting)

Conditions Post-stroke Depression; Healthy