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

Alzheimer Disease Clinical Trial

Official title:

Transcranial Pulse Stimulation for Alzheimer's Disease in an Open Prospective Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333329
• Other study ID #: STU_14_032
• Status: Completed
• Phase: N/A
• Start date: August 8, 2015
• Est. completion date: February 15, 2017

Study information

• Verified date: April 2020
• Source: Storz Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective open comprehensive proof-of-principle pilot study.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• NEUROLITH
transcranial pulse stimulation (TPS)

Locations

Country	Name	City	State
Germany	Rheintalklinik	Bad Krozingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Storz Medical AG	Rheintalklinik

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	3 months after treatment
Primary	Adverse Device Effects	Number of ADEs	within 3 months follow-up
Secondary	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".	Immediately post treatment (at 2 weeks)
Secondary	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".	1 month after treatment (at 6 weeks)
Secondary	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).	Immediately post treatment (at 2 weeks)
Secondary	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).	1 month after treatment (at 6 weeks)
Secondary	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).	3 months after treatment (at 14 weeks)
Secondary	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).	Immediately post treatment (at 2 weeks)
Secondary	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).	1 month after treatment (at 6 weeks)
Secondary	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).	3 months after treatment (at 14 weeks)
Secondary	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).	Immediately post treatment (at 2 weeks)
Secondary	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).	1 month after treatment (at 6 weeks)
Secondary	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).	3 months after treatment (at 14 weeks)
Secondary	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).	Immediately post treatment (at 2 weeks)
Secondary	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).	1 month after treatment (at 6 weeks)
Secondary	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).	3 months after treatment (at 14 weeks)