Clinical trial NCT05516680: Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD
Official title: Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD: a fMRI-based Single-center, Randomized, Controlled, Assessor-blinded Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-stroke Depression
Healthy
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction:

Post-stroke depression (PSD) is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life. Antidepressants are the first-line treatment for PSD, but many reported side effects remain. Clinical research and practice guidelines have shown that electro-acupuncture and rTMS have a positive effect on PSD. This trial aims to study the efficacy and safety of electro-acupuncture and a modern MRI-navigated rTMS for PSD and to explore its fMRI-based central mechanism on depression. It is hypothesized that electro-acupuncture and MRI-navigated rTMS treatment improves depressive symptoms, neuro-patho-physiological behaviors, quality of life and central response in PSD.

Methods:

In this randomized, controlled, assessors-blinded trial, sixty-four patients with PSD will be randomly allocated into the experiment group (n=32) or control group(n=32) . The experiment group will receive electro-acupuncture and MRI-navigated rTMS, and the control group will receive MRI-navigated rTMS treatment, in 12-20 sessions over 4 weeks. In addition, ten healthy people for fMRI scanning will be recruited as a healthy control group without any intervention. The primary outcome is the change from baseline in the Hamilton Depression Scale-24 items (HAMD-24) scores at week 4. The primary analysis of central mechanism mainly involves cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity based on fMRI at 0-wk and 4-wk. Secondary outcomes include the neuro-patho-physiological and quality of life changes in cortical excitability with motor evoked potential test(MEP), National Institutes of Health Stroke Scale(NIHSS), EuroQol Five Dimensions Questionnaire(EQ-5D) Scale, Modified Barthel Index(MBI) Scale and Short Form-Health Scale of Traditional Chinese Medicine(SF-HSTCM). Additional indicators include the Acceptability Questionnaire and Health Economics Evaluation (cost-effectiveness analysis) to assess acceptability and economic practicality of the treatment in study. Outcomes are assessed at baseline and post intervention.

Discussion:

Electro-acupuncture and MRI-navigated rTMS therapy could become an alternative treatment for PSD, and it is expected that this trial will provide reliable clinical evidence and potential effect mechanism for the future use of electro-acupuncture and MRI-navigated rTMS for PSD.


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.).

Primary outcomes:
measure: Hamilton Depression Scale-24 items scores
timeFrame: change from baseline to week 4
measure: fMRI scan
timeFrame: 0 week
measure: fMRI scan
timeFrame: 4 weeks
Secondary outcomes:
measure: motor evoked potential test
timeFrame: 0 week
measure: motor evoked potential test
timeFrame: 4 weeks
measure: National Institutes of Health Stroke Scale
timeFrame: 0 week
measure: National Institutes of Health Stroke Scale
timeFrame: 4 weeks
measure: EuroQol Five Dimensions Questionnaire Scale
timeFrame: 0 week
measure: EuroQol Five Dimensions Questionnaire Scale
timeFrame: 4 weeks
measure: Modified Barthel Index Scale
timeFrame: 0 week
measure: Modified Barthel Index Scale
timeFrame: 4 weeks
measure: Short Form-Health Scale of Traditional Chinese Medicine
timeFrame: 0 week
measure: Short Form-Health Scale of Traditional Chinese Medicine
timeFrame: 4 weeks
Other outcomes:
measure: Acceptability Questionnaire
timeFrame: 4 weeks
measure: Health Economics Evaluation
timeFrame: 4 weeks
Locations:
city: Nanjing
country: China
facility: Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
References: