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

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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Device: NEUROLITH

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Bad Krozingen, Baden-Württemberg, Germany, 79189
      • Rheintalklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AD Patients; 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	Device: NEUROLITH; transcranial pulse stimulation (TPS); Other Names: transcranial pulse stimulation (TPS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse Device Effects	Number of ADEs	within 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Storz Medical AG
• Collaborators: Rheintalklinik
• Investigators: Principal Investigator: Henning Lohse-Busch, MD, Rheintalklinik

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2015
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 15, 2017

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: STU_14_032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No