Lewy Body DementiatFUS in DLBNCT05499429
Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia
A study testing Transcranial low intensity focused ultrasound stimulation in people with Lewy Body Dementia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A randomized controlled clinical study was conducted in the xuanwu hospital Single Center of Capital Medical University to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with Lewy bodies in the early stage, to clarify the… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Lewy Body Dementia
- What is being tested?
- Transcranial low intensity focused ultrasound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female DLB patients between the ages of 50-85;
- The psychological evaluation was in accordance with MMSE score of 18-24 (including 18 and 24) and CDR score of 0.5.
- Can cooperate to complete clinical research.
Who cannot join
- There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging。
- Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.
- Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).
- Have a history of using antipsychotics for more than five years before diagnosis.
- There are contraindications for head MRI examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Single-center Randomized Controlled Trial of Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia
A randomized controlled clinical study was conducted in the xuanwu hospital Single Center of Capital Medical University to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with Lewy bodies in the early stage, to clarify the effective mechanism and form an effective clinical treatment plan.
Read the detailed description
This project plans to recruit 20 patients with mild Lewy body dementia.They were randomly divided into transcranial focused low-intensity ultrasound active stimulation group and sham stimulation group. Patients receive treatment three days a week, and the daily treatment time is 20-30 minutes.The duration of treatment is 4-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination of glucose metabolism were completed.Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination of glucose metabolism at the follow-up 6 months after the treatment.Fill in the treatment side effect scale and adverse event form.Keep the original oral drug dosage unchanged during the treatment process.
- Conditions
- Lewy Body Dementia
- Being tested
- Transcranial low intensity focused ultrasound stimulation
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial low intensity focused ultrasound stimulationDevice
Also called tFUS
Low intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force.
| Study group | Role | What they receive |
|---|---|---|
| active stimulus group | Active comparator | Patients were assigned into active stimulus group according to random number table Receives: Device: Transcranial low intensity focused ultrasound stimulation |
| sham stimulus control group | Sham comparator | Patients were assigned into sham stimulus control group according to random number table Receives: Device: Transcranial low intensity focused ultrasound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale
Evaluate the improvement of clinical symptoms.
Measured: 12 weeks
Secondary outcomes (2)
resting EEG
EEG power in alpha band
Measured: 12 weeks
head MRI
Changes of brain function by fMRI
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DementiaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Model description
- Patients were randomly assigned to the active stimulation group and sham stimulation group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499429
- Sponsor's protocol ID
- [2022]110
- Acronym
- tFUS in DLB
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Single-center Randomized Controlled Trial of Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia
- ClinicalTrials.gov ID
- NCT05499429
- Acronym / sponsor ID
- tFUS in DLB / [2022]110
- Conditions
- Lewy Body Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 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.
A randomized controlled clinical study was conducted in the xuanwu hospital Single Center of Capital Medical University to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with Lewy bodies in the early stage, to clarify the effective mechanism and form an effective clinical treatment plan.
Detailed description
This project plans to recruit 20 patients with mild Lewy body dementia.They were randomly divided into transcranial focused low-intensity ultrasound active stimulation group and sham stimulation group. Patients receive treatment three days a week, and the daily treatment time is 20-30 minutes.The duration of treatment is 4-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination of glucose metabolism were completed.Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination of glucose metabolism at the follow-up 6 months after the treatment.Fill in the treatment side effect scale and adverse event form.Keep the original oral drug dosage unchanged during the treatment process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned to the active stimulation group and sham stimulation group.
| Arm | Type | Receives |
|---|---|---|
| active stimulus group | Active comparator | Device: Transcranial low intensity focused ultrasound stimulationPatients were assigned into active stimulus group according to random number table |
| sham stimulus control group | Sham comparator | Device: Transcranial low intensity focused ultrasound stimulationPatients were assigned into sham stimulus control group according to random number table |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female DLB patients between the ages of 50-85;
- The psychological evaluation was in accordance with MMSE score of 18-24 (including 18 and 24) and CDR score of 0.5.
- Can cooperate to complete clinical research.
Key exclusion criteria (5 listed)
- There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging。
- Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.
- Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).
- Have a history of using antipsychotics for more than five years before diagnosis.
- There are contraindications for head MRI examination.
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 |
|---|---|---|
| Transcranial low intensity focused ultrasound stimulationAlso: tFUSLow intensity focused transcranial ultrasound stimulation can safely and effectively regulate neuron excitability through mechanical force. | Device | active stimulus group, sham stimulus control group |
Primary outcome
Clinical Global Impression Scale
Time frame: 12 weeks
Evaluate the improvement of clinical symptoms.
2 secondary outcomes
resting EEG
Time frame: 12 weeks
head MRI
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial low intensity focused ultrasound stimulation in people with Lewy Body Dementia, run by Xuanwu Hospital, Beijing 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Aug 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Penghu Wei, doctor (18601986863, weipenghu@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression Scale (time frame: 12 weeks). 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 12 Aug 2022.