Alzheimer DiseaseNCT05762926
Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease
A study testing Transcranial pulse stimulation (TPS) in people with Alzheimer Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Transcranial pulse stimulation (TPS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2023to 2 May 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who have Alzheimer's disease will be selected;
- Are aged ≥50 years;
- Medical assistance provided by the psychiatry service at IPQ;
- Who agree to participate after consent via the Informed Consent Term .
Who cannot join
- Make regular use of anticoagulants;
- Has skullcap failure, craniectomy without cranioplasty;
- Have a diagnosis of brain neoplasms or any type of nodule in the brain region;
- Have recent brain bleeds or a diagnosis of cerebral arteriovenous malformation;
- Be diagnosed with a type of dementia other than Alzheimer's;
- Have Mild Cognitive Impairment of the Elderly (MCI);
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- Have clinical changes that put the test at risk, such as severe cardiorespiratory disorders;
- Has a severe cognitive disorder that makes it impossible to apply therapy or questionnaires;
- It is clinically or socially impossible for the patient to attend IMREA for applications twice a week during the study period;
- Those who disagree to participate after consent via the Informed Consent Term .
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 04116-030
Marta Imamura, MD PhD, 55-11-5180-7897, marta.imamura@fm.usp.br
Artur Santos, 55-11-3905-8414, artur.santos@hc.fm.usp.br
About this study
This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo.
Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolith™ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.
- Conditions
- Alzheimer Disease
- Being tested
- Transcranial pulse stimulation (TPS)
- Keywords
- Alzheimer Disease, Transcranial Magnetic Stimulation, Extracorporeal Shockwave Therapy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial pulse stimulation (TPS)Other
Clinical treatment consists in ten sessions of neuronavigation system guided halocranial application of 6000 focused sound wave pulses, with energy flux density of 0.25 mJ/mm2, depth of focus of 5 cm and useful energy between 4 to 6 cm, frequency of 4 Hz, total energy applied will be 50 Joules, for it will be used the Storz Neurolith™ equipment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental: Neuronavigation system guided halocranial application of focused sound wave pulses, using the Storz Neurolith™ equipment. Receives: Other: Transcranial pulse stimulation (TPS) |
| Active Comparator | Active comparator | Neuronavigation system guided halocranial application without sound waves pulses, using the Storz Neurolith™ sham equipment, prepared to block the sound waves. Receives: Other: Transcranial pulse stimulation (TPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Functions
Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog)
Measured: Baseline and up to one, three, six and twelve months from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion2 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Imamura, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762926
- Sponsor's protocol ID
- CAAE 54939622.1.0000.0068
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) may be shared in the future under suitable request and justification to principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05762926
- Acronym / sponsor ID
- CAAE 54939622.1.0000.0068
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Transcranial Magnetic Stimulation, Extracorporeal Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 2 May 2024 (estimated)
- First posted
- 10 Mar 2023 (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, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo.
Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolith™ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Transcranial pulse stimulation (TPS)Experimental: Neuronavigation system guided halocranial application of focused sound wave pulses, using the Storz Neurolith™ equipment. |
| Active Comparator | Active comparator | Other: Transcranial pulse stimulation (TPS)Neuronavigation system guided halocranial application without sound waves pulses, using the Storz Neurolith™ sham equipment, prepared to block the sound waves. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who have Alzheimer's disease will be selected;
- Are aged ≥50 years;
- Medical assistance provided by the psychiatry service at IPQ;
- Who agree to participate after consent via the Informed Consent Term .
Key exclusion criteria (10 listed)
- Make regular use of anticoagulants;
- Has skullcap failure, craniectomy without cranioplasty;
- Have a diagnosis of brain neoplasms or any type of nodule in the brain region;
- Have recent brain bleeds or a diagnosis of cerebral arteriovenous malformation;
- Be diagnosed with a type of dementia other than Alzheimer's;
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 pulse stimulation (TPS)Clinical treatment consists in ten sessions of neuronavigation system guided halocranial application of 6000 focused sound wave pulses, with energy flux density of 0.25 mJ/mm2, depth of focus of 5 cm and useful energy between 4 to 6 cm, frequency of 4 Hz, total energy applied will be 50 Joules, for it will be used the Storz Neurolith™ equipment. | Other | Active Comparator, Experimental |
Primary outcome
Cognitive Functions
Time frame: Baseline and up to one, three, six and twelve months from intervention
Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) may be shared in the future under suitable request and justification to principal investigator.
Related trials for Alzheimer Disease
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Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
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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.
Marta Imamura, MD PhD principal investigator
University of Sao Paulo
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 pulse stimulation (TPS) in people with Alzheimer Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 18 Apr 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 Brazil. 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?
Contact Marta Imamura, MD PhD (55-11-5180-7897, marta.imamura@fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Functions (time frame: Baseline and up to one, three, six and twelve months from intervention). 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 18 Apr 2023.