Repetitive Transcranial Magnetic Stimulation (rTMS)NCT06743724
Repeated Transcranial Magnetic Stimulation Relieves Maternal Care Impairment
A study testing rTMS group in people with Repetitive Transcranial Magnetic Stimulation (rTMS) and Functional Magnetic Resonance Imaging, run by The First Affiliated Hospital of Soochow University at 2 sites in China.
Trial summary
Objective: To evaluate the overall efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of maternal care impairment (MCI) and to explore the central mechanism of rTMS for MCI. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Repetitive Transcranial Magnetic Stimulation (rTMS), Functional Magnetic Resonance Imaging, Maternal Care Patterns
- What is being tested?
- rTMS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jun 2024to 9 Apr 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy mothers.
- Aged between 18 and 45 years.
- No pharmacological treatment (excluding emergency treatment) for at least 2 weeks prior to the start of treatment; cannot be enrolled in other clinical trials simultaneously.
- Voluntarily sign the informed consent form and willingly participate in the clinical study.
Who cannot join
- Age below 18 years or above 45 years.
- Unmarried, nulliparous women.
- Individuals with severe liver, kidney, hematological diseases, cardiovascular diseases, or other conditions that significantly affect cognitive function.
- Participants with a clear history of organic diseases, or systemic conditions such as diabetes, hyperthyroidism, etc.
- Participants undergoing other treatments or taking medications that may interfere with the outcome assessment.
- Pregnant women, breastfeeding women, or women within six months postpartum.
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- Individuals with severe needle phobia, metal allergies, or allergic conditions, or those with a cardiac pacemaker.
- Participants who do not comply with random group assignment or have unstable tendencies such as poor adherence.
- Individuals currently participating in other research studies.
- Individuals unwilling to sign the informed consent form.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Soochow University
Suzhou, China, 215006
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Clinical Study of Repeated Transcranial Magnetic Stimulation(rTMS) for Maternal Care Impairment (MCI)
Objective: To evaluate the overall efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of maternal care impairment (MCI) and to explore the central mechanism of rTMS for MCI.
Design: Combined functional magnetic resonance imaging (fMRI) with Maternal Care Rating Scale (MCRS) were used to pinpoint hyperactive brain regions of patients with low MCRS score. Therefore, a clinical trial was performed to validate the therapeutic potential of rTMS in low MCRS score patients.
Read the detailed description
Background: Emotional dysregulation in patients with maternal care impairment represents a significant therapeutic challenge. While aberrant central processing is implicated, the key brain regions driving these negative emotional states and their suitability as neuromodulatory targets remain undefined.
Methods: Participants were randomly assigned (1:1) to the sham rTMS or rTMS group using a computer-generated randomization sequence created by an independent researcher who was not involved in recruitment, treatment, or outcome assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after baseline evaluations were completed. Both participants and outcome assessors were blinded to treatment allocation. The rTMS operators were not involved in data collection or analysis. For the sham condition, the coil was positioned identically over the anterior cingulate cortex (ACC) with magnetic output disabled, and prerecorded clicking sounds were delivered to mimic the acoustic sensation of stimulation. Participants were asked not to discuss treatment sensations with assessors. Scale raters and fMRI analysts remained blinded until all analyses were finalized.
For the nested fMRI cohort, randomization and blinding procedures were identical, with group allocation revealed only after preprocessing and statistical analysis had been completed.
- Conditions
- Repetitive Transcranial Magnetic Stimulation (rTMS), Functional Magnetic Resonance Imaging, Maternal Care Patterns
- Being tested
- rTMS group, Sham device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS groupDevice
Also called transcranial magnetic stimulation
Patients with low score of Maternal Care Rating Scale received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
Sham deviceDevice
For the sham rTMS group, the coil was placed over the ACC with the rTMS function disabled and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.
| Study group | Role | What they receive |
|---|---|---|
| Repeated transcranial magnetic stimulation group | Active comparator | The rTMS group was given 1 Hz/s for 20 min for 2 week. Receives: Device: rTMS group |
| Sham repetitive transcranial magnetic stimulation group | Sham comparator | For the sham rTMS group, the coil was placed over the ACC with the rTMS function disabled and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Care Rating Scale
The Maternal Care Rating Scale (MCRS) is a tool designed to assess and evaluate the quality of maternal care, including aspects of maternal behavior, emotional responses, and caregiving abilities. It focuses on the mother's ability to engage in positive, nurturing, and responsive interactions with her child. The scale can help identify variations in maternal care, such as maternal sensitivity, emotional support, and overall caregiving competence. In research, it is often used to measure the effectiveness of interventions aimed at improving maternal behavior or addressing maternal deficits, such as maternal care impairment (MCI).
Measured: End of the 2-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start14 Jun 2024
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Transcranial Magnetic Stimulation (rTMS)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow University
- Responsible party
- Sponsor
- Investigators
- Guangyin Xu, Prof., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743724
- Sponsor's protocol ID
- No.2024-117
- Other IDs
- 32230041
- Status last verified
- May 2026
- First submitted
- 7 Dec 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Repeated Transcranial Magnetic Stimulation(rTMS) for Maternal Care Impairment (MCI)
- ClinicalTrials.gov ID
- NCT06743724
- Acronym / sponsor ID
- No.2024-117
- Conditions
- Repetitive Transcranial Magnetic Stimulation (rTMS), Functional Magnetic Resonance Imaging, Maternal Care Patterns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Soochow University
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 20 Dec 2024 (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.
Objective: To evaluate the overall efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of maternal care impairment (MCI) and to explore the central mechanism of rTMS for MCI.
Design: Combined functional magnetic resonance imaging (fMRI) with Maternal Care Rating Scale (MCRS) were used to pinpoint hyperactive brain regions of patients with low MCRS score. Therefore, a clinical trial was performed to validate the therapeutic potential of rTMS in low MCRS score patients.
Detailed description
Background: Emotional dysregulation in patients with maternal care impairment represents a significant therapeutic challenge. While aberrant central processing is implicated, the key brain regions driving these negative emotional states and their suitability as neuromodulatory targets remain undefined.
Methods: Participants were randomly assigned (1:1) to the sham rTMS or rTMS group using a computer-generated randomization sequence created by an independent researcher who was not involved in recruitment, treatment, or outcome assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after baseline evaluations were completed. Both participants and outcome assessors were blinded to treatment allocation. The rTMS operators were not involved in data collection or analysis. For the sham condition, the coil was positioned identically over the anterior cingulate cortex (ACC) with magnetic output disabled, and prerecorded clicking sounds were delivered to mimic the acoustic sensation of stimulation. Participants were asked not to discuss treatment sensations with assessors. Scale raters and fMRI analysts remained blinded until all analyses were finalized.
For the nested fMRI cohort, randomization and blinding procedures were identical, with group allocation revealed only after preprocessing and statistical analysis had been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated transcranial magnetic stimulation group | Active comparator | Device: rTMS groupThe rTMS group was given 1 Hz/s for 20 min for 2 week. |
| Sham repetitive transcranial magnetic stimulation group | Sham comparator | Device: Sham deviceFor the sham rTMS group, the coil was placed over the ACC with the rTMS function disabled and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy mothers.
- Aged between 18 and 45 years.
- No pharmacological treatment (excluding emergency treatment) for at least 2 weeks prior to the start of treatment; cannot be enrolled in other clinical trials simultaneously.
- Voluntarily sign the informed consent form and willingly participate in the clinical study.
Key exclusion criteria (10 listed)
- Age below 18 years or above 45 years.
- Unmarried, nulliparous women.
- Individuals with severe liver, kidney, hematological diseases, cardiovascular diseases, or other conditions that significantly affect cognitive function.
- Participants with a clear history of organic diseases, or systemic conditions such as diabetes, hyperthyroidism, etc.
- Participants undergoing other treatments or taking medications that may interfere with the outcome assessment.
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 |
|---|---|---|
| rTMS groupAlso: transcranial magnetic stimulationPatients with low score of Maternal Care Rating Scale received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week. | Device | Repeated transcranial magnetic stimulation group |
| Sham deviceFor the sham rTMS group, the coil was placed over the ACC with the rTMS function disabled and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. | Device | Sham repetitive transcranial magnetic stimulation group |
Primary outcome
Maternal Care Rating Scale
Time frame: End of the 2-week treatment
The Maternal Care Rating Scale (MCRS) is a tool designed to assess and evaluate the quality of maternal care, including aspects of maternal behavior, emotional responses, and caregiving abilities. It focuses on the mother's ability to engage in positive, nurturing, and responsive interactions with her child. The scale can help identify variations in maternal care, such as maternal sensitivity, emotional support, and overall caregiving competence. In research, it is often used to measure the effectiveness of interventions aimed at improving maternal behavior or addressing maternal deficits, such as maternal care impairment (MCI).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.
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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.
Guangyin Xu, Prof. principal investigator
The First Affiliated Hospital of Soochow University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS group in people with Repetitive Transcranial Magnetic Stimulation (rTMS) and Functional Magnetic Resonance Imaging, run by The First Affiliated Hospital of Soochow University at 2 sites 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Care Rating Scale (time frame: End of the 2-week treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.