Post Stroke DepressionNCT06957340
Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combined With Upper Limb Virtual Reality Training on Post-Stroke Depression
A study testing Low-Intensity Transcranial Ultrasound Stimulation in people with Post Stroke Depression and Stroke, run by Anhui Medical University at 1 site in China.
Trial summary
Abstract: objective:To study whether post-stroke depression can be improved through low-intensity transcranial ultrasound stimulation combined with upper limb virtual reality training, explore its possible mechanisms, and provide new rehabilitation strategies for further treatment of post-stroke depression patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Stroke Depression, Stroke
- What is being tested?
- Low-Intensity Transcranial Ultrasound Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria were as follows:
- First-time stroke patients diagnosed with ischemic stroke via imaging techniques such as CT or MRI;
- Duration of the disease between 15 days and 6 months, with stable condition;Age between 18 and 75 years;
- Patients without severe intellectual, language comprehension, or behavioral impairments, capable of completing scale assessments, with an MMSE score of ≥24;
- Hemiplegia on one side and at least a 3rd-level seated balance, with Brunnstrom stage II or higher for the upper limb，able to perform movements with the assistance of the upper limb virtual reality training；
- No use of antidepressant medications in the past month, with PHQ-9 score≥10 and HAMA score≥17；
- Patients who are aware of the study details and have signed the informed consent form.
Who cannot join
- The exclusion criteria were as follows:
- Patients with metallic implants in the cranium or those with a pacemaker;
- Patients with unstable conditions, multiple brain infarctions, severe heart disease, or other significant organ conditions and complications, or a history of cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Abstract:
objective:To study whether post-stroke depression can be improved through low-intensity transcranial ultrasound stimulation combined with upper limb virtual reality training, explore its possible mechanisms, and provide new rehabilitation strategies for further treatment of post-stroke depression patients.
Read more
Methods:30 patients with PSD were selected as the subjects, and randomly divided into sham control group and combination treatment group according to computer randomization. Each group was 15 cases. The combined treatment group was subjected to LITUS, virtual reality upper limb training, routine medication and rehabilitation treatment. The control group only conducted virtual upper limb training, routine medication and rehabilitation treatment, and TUS was a false stimulation treatment.
Keywords:Ultrasoun,transcranial,ultrasound,stimulation,virtual reality,stroke,post-stroke depression
Read the detailed description
Abbreviation：Transcranial Ultrasound Stimulation(TUS),low intensity focused ultrasound (LIFU),low intensity transcranial Ultrasound stimulation(LITUS),virtual reality(VR),post-stroke depression(PSD),Wolf Motor Function Test(WFMT),Patient Health Questionnaire-9(PSQ-9),Hamilton Depression Scale(HAMD),Pittsburgh sleep quality index(PSQI)
- Conditions
- Post Stroke Depression, Stroke
- Being tested
- Low-Intensity Transcranial Ultrasound Stimulation, sham TUS
- Keywords
- stroke, post stroke depression, TUS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Transcranial Ultrasound StimulationDevice
LITUS is conducted using the UE880C model from RuAo Medical Technology Co., Ltd. (Beijing). The parameters are set as follows:Frequency: 800(1+10%) kHz,Pulse repetition period: 25 ms,Duty cycle: 50%,Output power: 1.2 W,Maximum output power duration: 0.6 W,Effective sound intensity: 0.4 W/cm².During treatment, the patient is placed in a quiet room and asked to relax in a seated position. Three ultrasound probes are coated with a coupling agent and positioned on the patient's forehead.The total treatment duration is 20 minutes.
The upper limb rehabilitation virtual training is used by the EM-BURT02-01 model from Eston.The affected limb is fixed to the robotic arm. Each treatment session consists of two virtual games (such as "Airplane Battle," "Mosquito Smasher," and other motion-based games).Each game lasts for 10 minutes, totaling 20 minutes of treatment. Treatment is administered 5 times a week.
sham TUSDevice
In the sham group, the machine only operates for 30 seconds, then stopping. Due to the physical characteristics of ultrasound, this stimulation cannot be perceived.Treatment is administered 5 times a week.
| Study group | Role | What they receive |
|---|---|---|
| sham TUS group | Sham comparator | The sham group only underwent upper limb virtual reality training, with LITUS serving as a placebo. Receives: Device: sham TUS |
| TUS group | Experimental | Low-Intensity Transcranial Ultrasound Stimulation combined with Upper Limb Virtual Reality Training Receives: Device: Low-Intensity Transcranial Ultrasound Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
WMFT
Wolf Motor Function Score: The Wolf Motor Function Test (WMFT) is the internationally preferred scale widely used to assess the effectiveness of rehabilitation training in improving upper limb function. It consists of 15 assessment items, many of which involve upper limb movements commonly used in daily life, such as placing the forearm on a table, grip strength, and fine motor skills. Each item is scored on a 6-point scale ranging from 0 to 5 based on the patient's functional performance, with higher scores indicating better function. The total score is 75. This assessment method is simple, easy to administer, does not easily fatigue the patient, and is particularly suitable for evaluating hand and upper limb functional recovery in stroke patients.
Measured: From enrollment to the end of treatment at 4 weeks
PHQ-9
PHQ-9 (Patient Health Questionnaire-9): The PHQ-9 is a commonly used screening tool for depression. It is based on the nine diagnostic criteria from the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, developed by the American Psychiatric Association). The scale is used to assess whether an individual has depression and to determine the severity of the condition. It has good reliability and validity, and its assessment is simple, quick, and well-accepted by patients. The total score is 27, with higher scores indicating greater severity of depression.
Measured: From enrollment to the end of treatment at 4 weeks
HAMD
The Hamilton Depression Rating Scale (HAMD) is one of the most widely used scales in clinical settings for assessing depressive states. Based on its assessment content, it has three versions; the HAMD-24 version is used here. This version includes multiple indicators such as mood, somatic symptoms, and sleep, allowing for an effective evaluation of the patient's functional improvement.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (2)
PSQI
Pittsburgh Sleep Quality Index (PSQI): The Pittsburgh Sleep Quality Index (PSQI) was developed in 1989 by Dr. Buysse and colleagues from the Department of Psychiatry at the University of Pittsburgh, USA. This scale is suitable for evaluating sleep quality in individuals with sleep and mental disorders, recording the patient's sleep quality over the past month. It consists of 19 items, which are scored and grouped into 7 components. Each component is rated from 0 to 3, with a total score of 21.
Measured: From enrollment to the end of treatment at 4 weeks
BDNF and 5-HT
Blood samples were collected at 7 a.m. The blood was centrifuged at 3500 r/min for 10 minutes to separate the serum.ELISA was used to measure brain-derived neurotrophic factor (BDNF) and serotonin (5-HT) levels. The measurements were taken both before treatment and 28 days after treatment.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jan 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke DepressionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingyan Zhuang, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957340
- Sponsor's protocol ID
- PJ2025-02-01
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on the Therapeutic Effect of Low-Intensity Transcranial Ultrasound Stimulation Combined With Upper Limb Virtual Reality Training on Post-Stroke Depression
- ClinicalTrials.gov ID
- NCT06957340
- Acronym / sponsor ID
- PJ2025-02-01
- Conditions
- Post Stroke Depression, Stroke
- Keywords
- stroke, post stroke depression, TUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 4 May 2025 (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.
Abstract:
objective:To study whether post-stroke depression can be improved through low-intensity transcranial ultrasound stimulation combined with upper limb virtual reality training, explore its possible mechanisms, and provide new rehabilitation strategies for further treatment of post-stroke depression patients.
Methods:30 patients with PSD were selected as the subjects, and randomly divided into sham control group and combination treatment group according to computer randomization. Each group was 15 cases. The combined treatment group was subjected to LITUS, virtual reality upper limb training, routine medication and rehabilitation treatment. The control group only conducted virtual upper limb training, routine medication and rehabilitation treatment, and TUS was a false stimulation treatment.
Keywords:Ultrasoun,transcranial,ultrasound,stimulation,virtual reality,stroke,post-stroke depression
Detailed description
Abbreviation：Transcranial Ultrasound Stimulation(TUS),low intensity focused ultrasound (LIFU),low intensity transcranial Ultrasound stimulation(LITUS),virtual reality(VR),post-stroke depression(PSD),Wolf Motor Function Test(WFMT),Patient Health Questionnaire-9(PSQ-9),Hamilton Depression Scale(HAMD),Pittsburgh sleep quality index(PSQI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham TUS group | Sham comparator | Device: sham TUSThe sham group only underwent upper limb virtual reality training, with LITUS serving as a placebo. |
| TUS group | Experimental | Device: Low-Intensity Transcranial Ultrasound StimulationLow-Intensity Transcranial Ultrasound Stimulation combined with Upper Limb Virtual Reality Training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The inclusion criteria were as follows:
Key exclusion criteria (3 listed)
- The exclusion criteria were as follows:
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 |
|---|---|---|
| Low-Intensity Transcranial Ultrasound StimulationLITUS is conducted using the UE880C model from RuAo Medical Technology Co., Ltd. (Beijing). The parameters are set as follows:Frequency: 800(1+10%) kHz,Pulse repetition period: 25 ms,Duty cycle: 50%,Output power: 1.2 W,Maximum output power duration: 0.6 W,Effective sound intensity: 0.4 W/cm².During treatment, the patient is placed in a quiet room and asked to relax in a seated position. Three ultrasound probes are coated with a coupling agent and positioned on the patient's forehead.The total treatment duration is 20 minutes. The upper limb rehabilitation virtual training is used by the EM-BURT02-01 model from Eston.The affected limb is fixed to the robotic arm. Each treatment session consists of two virtual games (such as "Airplane Battle," "Mosquito Smasher," and other motion-based games).Each game lasts for 10 minutes, totaling 20 minutes of treatment. Treatment is administered 5 times a week. | Device | TUS group |
| sham TUSIn the sham group, the machine only operates for 30 seconds, then stopping. Due to the physical characteristics of ultrasound, this stimulation cannot be perceived.Treatment is administered 5 times a week. | Device | sham TUS group |
Primary outcome
WMFT
Time frame: From enrollment to the end of treatment at 4 weeks
Wolf Motor Function Score: The Wolf Motor Function Test (WMFT) is the internationally preferred scale widely used to assess the effectiveness of rehabilitation training in improving upper limb function. It consists of 15 assessment items, many of which involve upper limb movements commonly used in daily life, such as placing the forearm on a table, grip strength, and fine motor skills. Each item is scored on a 6-point scale ranging from 0 to 5 based on the patient's functional performance, with higher scores indicating better function. The total score is 75. This assessment method is simple, easy to administer, does not easily fatigue the patient, and is particularly suitable for evaluating hand and upper limb functional recovery in stroke patients.
PHQ-9
Time frame: From enrollment to the end of treatment at 4 weeks
PHQ-9 (Patient Health Questionnaire-9): The PHQ-9 is a commonly used screening tool for depression. It is based on the nine diagnostic criteria from the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, developed by the American Psychiatric Association). The scale is used to assess whether an individual has depression and to determine the severity of the condition. It has good reliability and validity, and its assessment is simple, quick, and well-accepted by patients. The total score is 27, with higher scores indicating greater severity of depression.
HAMD
Time frame: From enrollment to the end of treatment at 4 weeks
The Hamilton Depression Rating Scale (HAMD) is one of the most widely used scales in clinical settings for assessing depressive states. Based on its assessment content, it has three versions; the HAMD-24 version is used here. This version includes multiple indicators such as mood, somatic symptoms, and sleep, allowing for an effective evaluation of the patient's functional improvement.
2 secondary outcomes
PSQI
Time frame: From enrollment to the end of treatment at 4 weeks
BDNF and 5-HT
Time frame: From enrollment to the end of treatment at 4 weeks
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 4 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Transcranial Ultrasound Stimulation in people with Post Stroke Depression and Stroke, run by Anhui Medical University 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 7 inclusion and 3 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 4 May 2025. 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. 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?
WMFT (time frame: From enrollment to the end of treatment at 4 weeks). 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?
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 4 May 2025.