Post-stroke DepressionNCT05516680
Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD
A study testing electro-acupuncture and MRI-navigated rTMS in people with Post-stroke Depression and Healthy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Depression, Healthy
- What is being tested?
- electro-acupuncture and MRI-navigated rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2022to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
- Healthy subjects, aged 40-75 years;
- Right-handed;
- HAMD-24 score < 8;
- Sign the informed consent voluntarily.
Who cannot join
- 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.).
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- 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.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210008
Jian Wang, 13809005974, kejiaochu-2001@163.com
Hai Lu, Ph.D
About this study
Official title: Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD: a fMRI-based Single-center, Randomized, Controlled, Assessor-blinded Trial
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.
Read more
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.
- Conditions
- Post-stroke Depression, Healthy
- Being tested
- electro-acupuncture, MRI-navigated rTMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-acupunctureDevice
Acupoints consist of Neiguan (PC6, bilateral), Shuigou (GV26), Sanyinjiao (SP6, affected side), Yintang (EX-HN3), Shangxing (GV23), Baihui (GV20), and Sishencong (EX-HN1). Disposable stainless-steel needles (0.25mm× 40 mm）will be used. After skin disinfection, the acupuncturists will twist and thrust the needle handles to achieve the sensation of achiness, heaviness, and numbness (known as de qi) at all acupoints. Following needle manipulations, electroacupuncture instruments(SDZ-V) will be used to attached the needle handles at EX-HN3, GV23, GV20 and EX-HN1 with a dilatational wave of 5 ~ 10 Hz and a current intensity of 1 ~ 3 mA depending on the patient's tolerance. The needles will be removed after 30 minutes except for GV26 without needle retention. Participants will receive 12-20 electroacupuncture sessions over four weeks at a frequency of 3-5 times per week.
MRI-navigated rTMSDevice
MRI:All MRI scans were taken to acquire high-resolution T1-weighted anatomical images on the 3T MRI Scanner. Electromyography(EMG):Surface EMG was used to record MEPs from the abductor pollicis brevis for determining RMT of the non-lesioned motor cortex.A single TMS pulse was delivered to the location to identify the RMT,defined as the minimum intensity capable of evoking at least 5 MEPs of >50 μV in 10 consecutive trials.MRI-navigated rTMS:Using BrainSight system,left DLPFC targeting was individualized by reconstructing MRI data into a 3-dimensional brain image for neuro-navigation. Left DLPFC localization was central middle frontal gyrus,between superior frontal sulcus and middle frontal sulcus based on T1-weighted anatomical images.Focal rTMS was administered using a Magstim Rapid 2 connected to Y125-round coil that was identical.rTMS was applied at 110% RMT to the left DLPFC.At each session,3000 pulses were applied at 10 Hz with a total of 12-20 rTMS sessions over a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | electro-acupuncture and MRI-navigated rTMS Receives: Device: electro-acupuncture; Device: MRI-navigated rTMS |
| Control group | Active comparator | MRI-navigated rTMS Receives: Device: MRI-navigated rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale-24 items scores
Reduction rate
Measured: change from baseline to week 4
fMRI scan
Cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity
Measured: 0 week
fMRI scan
Cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity
Measured: 4 weeks
Secondary outcomes (10)
motor evoked potential test
Cortical excitability
Measured: 0 week
motor evoked potential test
Cortical excitability
Measured: 4 weeks
National Institutes of Health Stroke Scale
The minimum and maximum values are 0 and 42 points, and higher scores mean a worse outcome.
Measured: 0 week
National Institutes of Health Stroke Scale
The minimum and maximum values are 0 and 42 points, and higher scores mean a worse outcome.
Measured: 4 weeks
EuroQol Five Dimensions Questionnaire Scale
The minimum and maximum values of utility index are -0.391 and 1 points, and higher scores mean a better outcome.
Measured: 0 week
EuroQol Five Dimensions Questionnaire Scale
The minimum and maximum values of utility index are -0.391 and 1 points, and higher scores mean a better outcome.
Measured: 4 weeks
Modified Barthel Index Scale
The minimum and maximum values are 0 and 100 points, and higher scores mean a better outcome.
Measured: 0 week
Modified Barthel Index Scale
The minimum and maximum values are 0 and 100 points, and higher scores mean a better outcome.
Measured: 4 weeks
Short Form-Health Scale of Traditional Chinese Medicine
The minimum and maximum values are 0 and 130 points, and higher scores mean a worse outcome.
Measured: 0 week
Short Form-Health Scale of Traditional Chinese Medicine
The minimum and maximum values are 0 and 130 points, and higher scores mean a worse outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start22 Oct 2022
- Primary completion30 Jun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516680
- Sponsor's protocol ID
- 2022-LCYJ-PY-08
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD sharing will be made during the 6 months after the end of study, and the original data can be obtained from the PI if necessary.
Publications
Lu H, Wang Y, Shen D, Ruan J, Lu J, Wang L, Song Y, Fan J, Li D, Shi L, Xia M, Xu T. Effects and central mechanism of electroacupuncture and MRI-navigated rTMS for PSD: study protocol for an fMRI-based single-center, randomized, controlled, open-label trial. Front Psychiatry. 2024 Jan 4;14:1226777. doi: 10.3389/fpsyt.2023.1226777. eCollection 2023.
PubMed 38250275
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD: a fMRI-based Single-center, Randomized, Controlled, Assessor-blinded Trial
- ClinicalTrials.gov ID
- NCT05516680
- Acronym / sponsor ID
- 2022-LCYJ-PY-08
- Conditions
- Post-stroke Depression, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment group | Experimental | Device: electro-acupuncture, Device: MRI-navigated rTMSelectro-acupuncture and MRI-navigated rTMS |
| Control group | Active comparator | Device: MRI-navigated rTMSMRI-navigated rTMS |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electro-acupunctureAcupoints consist of Neiguan (PC6, bilateral), Shuigou (GV26), Sanyinjiao (SP6, affected side), Yintang (EX-HN3), Shangxing (GV23), Baihui (GV20), and Sishencong (EX-HN1). Disposable stainless-steel needles (0.25mm× 40 mm）will be used. After skin disinfection, the acupuncturists will twist and thrust the needle handles to achieve the sensation of achiness, heaviness, and numbness (known as de qi) at all acupoints. Following needle manipulations, electroacupuncture instruments(SDZ-V) will be used to attached the needle handles at EX-HN3, GV23, GV20 and EX-HN1 with a dilatational wave of 5 ~ 10 Hz and a current intensity of 1 ~ 3 mA depending on the patient's tolerance. The needles will be removed after 30 minutes except for GV26 without needle retention. Participants will receive 12-20 electroacupuncture sessions over four weeks at a frequency of 3-5 times per week. | Device | Experiment group |
| MRI-navigated rTMSMRI:All MRI scans were taken to acquire high-resolution T1-weighted anatomical images on the 3T MRI Scanner. Electromyography(EMG):Surface EMG was used to record MEPs from the abductor pollicis brevis for determining RMT of the non-lesioned motor cortex.A single TMS pulse was delivered to the location to identify the RMT,defined as the minimum intensity capable of evoking at least 5 MEPs of >50 μV in 10 consecutive trials.MRI-navigated rTMS:Using BrainSight system,left DLPFC targeting was individualized by reconstructing MRI data into a 3-dimensional brain image for neuro-navigation. Left DLPFC localization was central middle frontal gyrus,between superior frontal sulcus and middle frontal sulcus based on T1-weighted anatomical images.Focal rTMS was administered using a Magstim Rapid 2 connected to Y125-round coil that was identical.rTMS was applied at 110% RMT to the left DLPFC.At each session,3000 pulses were applied at 10 Hz with a total of 12-20 rTMS sessions over a 4-week period. | Device | Control group, Experiment group |
Primary outcome
Hamilton Depression Scale-24 items scores
Time frame: change from baseline to week 4
Reduction rate
fMRI scan
Time frame: 0 week
Cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity
fMRI scan
Time frame: 4 weeks
Cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity
10 secondary outcomes
motor evoked potential test
Time frame: 0 week
motor evoked potential test
Time frame: 4 weeks
National Institutes of Health Stroke Scale
Time frame: 0 week
National Institutes of Health Stroke Scale
Time frame: 4 weeks
EuroQol Five Dimensions Questionnaire Scale
Time frame: 0 week
EuroQol Five Dimensions Questionnaire Scale
Time frame: 4 weeks
Modified Barthel Index Scale
Time frame: 0 week
Modified Barthel Index Scale
Time frame: 4 weeks
Short Form-Health Scale of Traditional Chinese Medicine
Time frame: 0 week
Short Form-Health Scale of Traditional Chinese Medicine
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 38250275Lu H, Wang Y, Shen D, Ruan J, Lu J, Wang L, Song Y, Fan J, Li D, Shi L, Xia M, Xu T. Effects and central mechanism of electroacupuncture and MRI-navigated rTMS for PSD: study protocol for an fMRI-based single-center, randomized, controlled, open-label trial. Front Psychiatry. 2024 Jan 4;14:1226777. doi: 10.3389/fpsyt.2023.1226777. eCollection 2023.
- Individual participant dataSharing planned: Yes. IPD sharing will be made during the 6 months after the end of study, and the original data can be obtained from the PI if necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drum Tower Hospital, Medical School of Nanjing University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electro-acupuncture and MRI-navigated rTMS in people with Post-stroke Depression and Healthy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale-24 items scores (time frame: change from baseline to week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.