StrokePSD fNIRS rTMSNCT06723769
Efficacy of Repeated Transcranial Magnetic Stimulation Based on Near-infrared Imaging in Patients With Post-stroke Depression
A study testing rTMS treatment and conventional treatment in people with Stroke and Post-stroke Depression, run by Dingqun Bai at 1 site in China.
Trial summary
This is a randomized controlled trial to evaluate the efficacy and safety of Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in post-stroke depression (PSD), explore mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Post-stroke Depression
- What is being tested?
- rTMS treatment and conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 29 Feb 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Hospitalized patients over 18 years of age; (2) Meet the stroke diagnostic criteria of the Fourth National Conference on Cerebrovascular Diseases and have been confirmed as ischemic or hemorrhagic stroke by head CT and MRI; (3) Symptoms of PSD such as low mood, loss of interest in daily life, insomnia, or poor appetite persist for more than 1 week and meet the inclusion criteria of the DSM-5; (4) Hamilton Depression Scale score-17 (HAMD) > 7; (5) Stable vital signs, willing to accept the treatment method of this study, and sign the informed consent for treatment.
Who cannot join
- (1) Patients with a history of mental disorders and depression before stroke onset; (2) Patients with consciousness disorder, severe aphasia or comprehension and expression disorder after stroke; (3) Patients with serious cognitive impairment can not cooperate with the psychological evaluator; (4) Patients with metal implants in the skull; (5) People with cardiac pacemakers; (6) Previous head trauma, alcoholism, or family history of epilepsy and another risk of seizures; (7) psychotic symptoms such as agitation, speech and behavior disorder; (8) refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rehabilitation Medicine, the First Affiliated Hospital of Chongqing Medical University, Chongqing,, Chongqing, Chongqing 400010
Chongqing, Chongqing Municipality, 400010
About this study
Official title: Efficacy and Safety of Low-frequency Repetitive Transcranial Magnetic Stimulation in Post-stroke Depression: a Randomized Controlled fNIRS Study
This is a randomized controlled trial to evaluate the efficacy and safety of Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in post-stroke depression (PSD), explore mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).
Read the detailed description
To evaluate the efficacy and safety of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) for the right dorsolateral prefrontal cortex (DLPFC) in patients with post-stroke depression (PSD), and explore the possible neural mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).
Patients were randomly assigned to the rTMS and control groups. the treatment effect was assessed by the Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI). Meanwhile, fNIRS was used to detect the changes of blood oxygen concentration in the frontal cortex.
After treatment, the score of the HAMD scale in the rTMS group decreased more significantly than in the control group (P<0.05). The value of CH17 oxyhemoglobin (HBO) and the value of CH6 deoxyhemoglobin (HBR) were decreased after rTMS. The HbR of CH6 and CH8 decreased significantly, the HbR of CH12 and CH15 increased significantly (P<0.05). The HAMA, NIHSS and Barthel scores improved more significantly in the rTMS group.
- Conditions
- Stroke, Post-stroke Depression
- Being tested
- rTMS treatment, conventional treatment
- Keywords
- fNIRS, LF-rTMS, DLPFC
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS treatmentDevice
Repetitive transcranial magnetic stimulation (rTMS) is a new physiotherapy technique for the treatment of PSD Compared to other strategies, it has the advantages of simple operation, non-invasive, painless, and safe. Studies have comprehensively shown that rTMS can effectively improve depressive symptoms in PSD patients
conventional treatmentOther
general treatment of stabilizing vital signs (such as antidepressants, stabilizing blood pressure, stabilizing blood sugar, etc. ) and conventional rehabilitation treatment (hemiplegic limb comprehensive training, swallowing speech training, cognitive perception training, etc. ).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | conventional treatment Receives: Other: conventional treatment |
| rTMS group | Experimental | The rTMS group was treated with LF-rTMS based on the conventional treatment. Receives: Device: rTMS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAMD-17)
evaluate the degree of depression
Measured: pre and post 4 weeks treatment
Functional near-infrared spectroscopy (fNIRS assessment)
measure brain function to determine the effect of rTMS on cerebral blood flow change
Measured: pre and post 4 weeks treatment
Secondary outcomes (3)
Hamilton Anxiety Scale(HAMA)
evaluate the degree of anxiety
Measured: pre and post 4 weeks treatment
National Institutes of Health Stroke Scale(NIHSS)
evaluate the degree of neurological impairment
Measured: pre and post 4 weeks treatment
Barthel Index(BI)
evaluate the degree of daily living ability
Measured: pre and post 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jun 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dingqun Bai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dingqun Bai, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Dingqun Bai, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723769
- Sponsor's protocol ID
- 20241204
- Acronym
- PSD fNIRS rTMS
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-frequency Repetitive Transcranial Magnetic Stimulation in Post-stroke Depression: a Randomized Controlled fNIRS Study
- ClinicalTrials.gov ID
- NCT06723769
- Acronym / sponsor ID
- PSD fNIRS rTMS / 20241204
- Conditions
- Stroke, Post-stroke Depression
- Keywords
- fNIRS, LF-rTMS, DLPFC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dingqun BaiUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 9 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.
This is a randomized controlled trial to evaluate the efficacy and safety of Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in post-stroke depression (PSD), explore mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).
Detailed description
To evaluate the efficacy and safety of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) for the right dorsolateral prefrontal cortex (DLPFC) in patients with post-stroke depression (PSD), and explore the possible neural mechanism of rTMS with Functional near-infrared spectroscopy (fNIRS).
Patients were randomly assigned to the rTMS and control groups. the treatment effect was assessed by the Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), National Institutes of Health Stroke Scale (NIHSS), and Barthel Index (BI). Meanwhile, fNIRS was used to detect the changes of blood oxygen concentration in the frontal cortex.
After treatment, the score of the HAMD scale in the rTMS group decreased more significantly than in the control group (P<0.05). The value of CH17 oxyhemoglobin (HBO) and the value of CH6 deoxyhemoglobin (HBR) were decreased after rTMS. The HbR of CH6 and CH8 decreased significantly, the HbR of CH12 and CH15 increased significantly (P<0.05). The HAMA, NIHSS and Barthel scores improved more significantly in the rTMS group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: conventional treatmentconventional treatment |
| rTMS group | Experimental | Device: rTMS treatmentThe rTMS group was treated with LF-rTMS based on the conventional treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Hospitalized patients over 18 years of age; (2) Meet the stroke diagnostic criteria of the Fourth National Conference on Cerebrovascular Diseases and have been confirmed as ischemic or hemorrhagic stroke by head CT and MRI; (3) Symptoms of PSD such as low mood, loss of interest in daily life, insomnia, or poor appetite persist for more than 1 week and meet the inclusion criteria of the DSM-5; (4) Hamilton Depression Scale score-17 (HAMD) > 7; (5) Stable vital signs, willing to accept the treatment method of this study, and sign the informed consent for treatment.
Key exclusion criteria (1 listed)
- (1) Patients with a history of mental disorders and depression before stroke onset; (2) Patients with consciousness disorder, severe aphasia or comprehension and expression disorder after stroke; (3) Patients with serious cognitive impairment can not cooperate with the psychological evaluator; (4) Patients with metal implants in the skull; (5) People with cardiac pacemakers; (6) Previous head trauma, alcoholism, or family history of epilepsy and another risk of seizures; (7) psychotic symptoms such as agitation, speech and behavior disorder; (8) refuse to sign the informed consent.
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 treatmentRepetitive transcranial magnetic stimulation (rTMS) is a new physiotherapy technique for the treatment of PSD Compared to other strategies, it has the advantages of simple operation, non-invasive, painless, and safe. Studies have comprehensively shown that rTMS can effectively improve depressive symptoms in PSD patients | Device | rTMS group |
| conventional treatmentgeneral treatment of stabilizing vital signs (such as antidepressants, stabilizing blood pressure, stabilizing blood sugar, etc. ) and conventional rehabilitation treatment (hemiplegic limb comprehensive training, swallowing speech training, cognitive perception training, etc. ). | Other | Control group |
Primary outcome
Hamilton Depression Scale (HAMD-17)
Time frame: pre and post 4 weeks treatment
evaluate the degree of depression
Functional near-infrared spectroscopy (fNIRS assessment)
Time frame: pre and post 4 weeks treatment
measure brain function to determine the effect of rTMS on cerebral blood flow change
3 secondary outcomes
Hamilton Anxiety Scale(HAMA)
Time frame: pre and post 4 weeks treatment
National Institutes of Health Stroke Scale(NIHSS)
Time frame: pre and post 4 weeks treatment
Barthel Index(BI)
Time frame: pre and post 4 weeks treatment
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 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Dingqun Bai study chair
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS treatment and conventional treatment in people with Stroke and Post-stroke Depression, run by Dingqun Bai 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 1 inclusion and 1 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 9 Dec 2024. 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?
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?
Hamilton Depression Scale (HAMD-17) (time frame: pre and post 4 weeks treatment). The study lists 2 primary outcomes in all. 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 9 Dec 2024.