Alzheimer DiseaseNCT04333329
Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)
A study testing NEUROLITH in people with Alzheimer Disease, run by Storz Medical AG at 1 site in Germany.
Trial summary
This is a prospective open comprehensive proof-of-principle pilot study. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NEUROLITH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 8 Aug 2015to 15 Feb 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
- MMSE ≥ 10: Mild and moderate Alzheimer's Disease according to AWMF Register, S3 Guidelines of DGN 038/013 and DEGAM 035/021
- At least 3 months of stable antidementia therapy or no antidementia therapy necessary (Patients need to continue their standard treatment within the clinical investigation according to the guidelines as TPS is considered an additional treatment to standard therapy)
- Signed written informed consent
- 18 years ≤ Age ≤ 85 years
- Monthly pregnancy tests for female patients in childbearing age
Who cannot join
- Non-compliance with the protocol (including CERAD-plus)
- Pregnancy
- Breast-feeding women
- Microbubbles (contrast agents) in application area
- Cerebral pathology unrelated to Alzheimer's disease
- Metallic objects in the head
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- Neurosurgical intervention of the brain / Craniotomy
- Cardiac disorders
- History of psychiatric diseases before development of dementia
- Hemophilia or other blood clotting disorders
- Cortisone treatment up to 6 months before first treatment
- Other conditions implying increased risk according to the judgement of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Pulse Stimulation for Alzheimer's Disease in an Open Prospective Pilot Study
This is a prospective open comprehensive proof-of-principle pilot study.
Read the detailed description
This is a prospective open comprehensive proof-of-principle pilot study with patients of mild to moderate Alzheimer's Disease who have been treated with transcranial pulse stimulation (TPS)
- Conditions
- Alzheimer Disease
- Being tested
- NEUROLITH
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROLITHDevice
Also called transcranial pulse stimulation (TPS)
transcranial pulse stimulation (TPS)
| Study group | Role | What they receive |
|---|---|---|
| AD Patients | Experimental | All patients were treated with the TPS device (new name: NEUROLITH (Storz Medical AG))
- 6 sessions within 2 weeks, each sessions consisting of 6000 TPS pulses of 0.2 mJ/mm² Receives: Device: NEUROLITH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
CERAD is a cognitive test battery which is normalized for age, gender and education. The CERAD total score ranges from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
Measured: 3 months after treatment
Adverse Device Effects
Number of ADEs
Measured: within 3 months follow-up
Secondary outcomes (14)
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
CERAD is a cognitive test battery which is normalized for age, gender and education. The CERAD total score ranges from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
Measured: Immediately post treatment (at 2 weeks)
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
CERAD is a cognitive test battery which is normalized for age, gender and education. The CERAD total score ranges from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
Measured: 1 month after treatment (at 6 weeks)
Mini-Mental-State Examination (MMSE)
The MMSE consists of 10 items that cover orientation, short term memory, attentional capabilities, arithmetic performance and language functions. Scoring is possible between 0 (worst) and 30 (best).
Measured: Immediately post treatment (at 2 weeks)
Mini-Mental-State Examination (MMSE)
The MMSE consists of 10 items that cover orientation, short term memory, attentional capabilities, arithmetic performance and language functions. Scoring is possible between 0 (worst) and 30 (best).
Measured: 1 month after treatment (at 6 weeks)
Mini-Mental-State Examination (MMSE)
The MMSE consists of 10 items that cover orientation, short term memory, attentional capabilities, arithmetic performance and language functions. Scoring is possible between 0 (worst) and 30 (best).
Measured: 3 months after treatment (at 14 weeks)
Clock Drawing Test (CDT)
The clock drawing test is used to assess visuoconstruction abilities. The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).
Measured: Immediately post treatment (at 2 weeks)
Clock Drawing Test (CDT)
The clock drawing test is used to assess visuoconstruction abilities. The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).
Measured: 1 month after treatment (at 6 weeks)
Clock Drawing Test (CDT)
The clock drawing test is used to assess visuoconstruction abilities. The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).
Measured: 3 months after treatment (at 14 weeks)
Beck Depression Inventory (BDI)
The BDI measures the severity of depression. It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
Measured: Immediately post treatment (at 2 weeks)
Beck Depression Inventory (BDI)
The BDI measures the severity of depression. It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
Measured: 1 month after treatment (at 6 weeks)
Beck Depression Inventory (BDI)
The BDI measures the severity of depression. It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
Measured: 3 months after treatment (at 14 weeks)
Geriatric Depression Scale - short form (GDS-15)
The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
Measured: Immediately post treatment (at 2 weeks)
Geriatric Depression Scale - short form (GDS-15)
The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
Measured: 1 month after treatment (at 6 weeks)
Geriatric Depression Scale - short form (GDS-15)
The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
Measured: 3 months after treatment (at 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start8 Aug 2015
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Storz Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rheintalklinik
- Responsible party
- Sponsor
- Investigators
- Henning Lohse-Busch, MD, Principal investigator, Rheintalklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333329
- Sponsor's protocol ID
- STU_14_032
- Status last verified
- Apr 2020
- First submitted
- 6 Sep 2018
- Last updated
- 3 Apr 2020
- 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 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Pulse Stimulation for Alzheimer's Disease in an Open Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04333329
- Acronym / sponsor ID
- STU_14_032
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Storz Medical AGIndustry (pharma, biotech, devices)
- Collaborators
- Rheintalklinik
- Study start
- 8 Aug 2015 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 3 Apr 2020 (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 prospective open comprehensive proof-of-principle pilot study.
Detailed description
This is a prospective open comprehensive proof-of-principle pilot study with patients of mild to moderate Alzheimer's Disease who have been treated with transcranial pulse stimulation (TPS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD Patients | Experimental | Device: NEUROLITHAll patients were treated with the TPS device (new name: NEUROLITH (Storz Medical AG)) - 6 sessions within 2 weeks, each sessions consisting of 6000 TPS pulses of 0.2 mJ/mm² |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
- MMSE ≥ 10: Mild and moderate Alzheimer's Disease according to AWMF Register, S3 Guidelines of DGN 038/013 and DEGAM 035/021
- At least 3 months of stable antidementia therapy or no antidementia therapy necessary (Patients need to continue their standard treatment within the clinical investigation according to the guidelines as TPS is considered an additional treatment to standard therapy)
- Signed written informed consent
- 18 years ≤ Age ≤ 85 years
Key exclusion criteria (12 listed)
- Non-compliance with the protocol (including CERAD-plus)
- Pregnancy
- Breast-feeding women
- Microbubbles (contrast agents) in application area
- Cerebral pathology unrelated to Alzheimer's disease
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 |
|---|---|---|
| NEUROLITHAlso: transcranial pulse stimulation (TPS)transcranial pulse stimulation (TPS) | Device | AD Patients |
Primary outcome
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
Time frame: 3 months after treatment
CERAD is a cognitive test battery which is normalized for age, gender and education. The CERAD total score ranges from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
Adverse Device Effects
Time frame: within 3 months follow-up
Number of ADEs
14 secondary outcomes
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
Time frame: Immediately post treatment (at 2 weeks)
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
Time frame: 1 month after treatment (at 6 weeks)
Mini-Mental-State Examination (MMSE)
Time frame: Immediately post treatment (at 2 weeks)
Mini-Mental-State Examination (MMSE)
Time frame: 1 month after treatment (at 6 weeks)
Mini-Mental-State Examination (MMSE)
Time frame: 3 months after treatment (at 14 weeks)
Clock Drawing Test (CDT)
Time frame: Immediately post treatment (at 2 weeks)
Clock Drawing Test (CDT)
Time frame: 1 month after treatment (at 6 weeks)
Clock Drawing Test (CDT)
Time frame: 3 months after treatment (at 14 weeks)
Beck Depression Inventory (BDI)
Time frame: Immediately post treatment (at 2 weeks)
Beck Depression Inventory (BDI)
Time frame: 1 month after treatment (at 6 weeks)
Beck Depression Inventory (BDI)
Time frame: 3 months after treatment (at 14 weeks)
Geriatric Depression Scale - short form (GDS-15)
Time frame: Immediately post treatment (at 2 weeks)
Geriatric Depression Scale - short form (GDS-15)
Time frame: 1 month after treatment (at 6 weeks)
Geriatric Depression Scale - short form (GDS-15)
Time frame: 3 months after treatment (at 14 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 3 Apr 2020.
- 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.
Henning Lohse-Busch, MD principal investigator
Rheintalklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUROLITH in people with Alzheimer Disease, run by Storz Medical AG at 1 site in Germany.
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 6 inclusion and 12 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 3 Apr 2020. 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 Germany. 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?
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score (time frame: 3 months after 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 3 Apr 2020.