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Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NEUROLITH
Sponsored by
Storz Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Rheintalklinik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AD Patients

Arm Description

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

Outcomes

Primary Outcome Measures

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".
Adverse Device Effects
Number of ADEs

Secondary Outcome Measures

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".
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".
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
September 6, 2018
Last Updated
April 1, 2020
Sponsor
Storz Medical AG
Collaborators
Rheintalklinik
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1. Study Identification

Unique Protocol Identification Number
NCT04333329
Brief Title
Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)
Official Title
Transcranial Pulse Stimulation for Alzheimer's Disease in an Open Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2015 (Actual)
Primary Completion Date
February 15, 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Storz Medical AG
Collaborators
Rheintalklinik

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD Patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
NEUROLITH
Other Intervention Name(s)
transcranial pulse stimulation (TPS)
Intervention Description
transcranial pulse stimulation (TPS)
Primary Outcome Measure Information:
Title
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
Description
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".
Time Frame
3 months after treatment
Title
Adverse Device Effects
Description
Number of ADEs
Time Frame
within 3 months follow-up
Secondary Outcome Measure Information:
Title
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
Description
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".
Time Frame
Immediately post treatment (at 2 weeks)
Title
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score
Description
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".
Time Frame
1 month after treatment (at 6 weeks)
Title
Mini-Mental-State Examination (MMSE)
Description
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).
Time Frame
Immediately post treatment (at 2 weeks)
Title
Mini-Mental-State Examination (MMSE)
Description
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).
Time Frame
1 month after treatment (at 6 weeks)
Title
Mini-Mental-State Examination (MMSE)
Description
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).
Time Frame
3 months after treatment (at 14 weeks)
Title
Clock Drawing Test (CDT)
Description
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).
Time Frame
Immediately post treatment (at 2 weeks)
Title
Clock Drawing Test (CDT)
Description
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).
Time Frame
1 month after treatment (at 6 weeks)
Title
Clock Drawing Test (CDT)
Description
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).
Time Frame
3 months after treatment (at 14 weeks)
Title
Beck Depression Inventory (BDI)
Description
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).
Time Frame
Immediately post treatment (at 2 weeks)
Title
Beck Depression Inventory (BDI)
Description
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).
Time Frame
1 month after treatment (at 6 weeks)
Title
Beck Depression Inventory (BDI)
Description
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).
Time Frame
3 months after treatment (at 14 weeks)
Title
Geriatric Depression Scale - short form (GDS-15)
Description
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).
Time Frame
Immediately post treatment (at 2 weeks)
Title
Geriatric Depression Scale - short form (GDS-15)
Description
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).
Time Frame
1 month after treatment (at 6 weeks)
Title
Geriatric Depression Scale - short form (GDS-15)
Description
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).
Time Frame
3 months after treatment (at 14 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Lohse-Busch, MD
Organizational Affiliation
Rheintalklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheintalklinik
City
Bad Krozingen
State/Province
Baden-Württemberg
ZIP/Postal Code
79189
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)

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