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Completed

NCT Number: NCT04333329

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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rheintalklinik

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NEUROLITH

Device

transcranial pulse stimulation (TPS)

Other names: transcranial pulse stimulation (TPS)

Primary outcomes

  1. 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".

  2. Adverse Device Effects

    Time frame: within 3 months follow-up

    Number of ADEs

Secondary outcomes

  1. Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score

    Time frame: Immediately post treatment (at 2 weeks)

    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".

  2. Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Total Score

    Time frame: 1 month after treatment (at 6 weeks)

    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. Mini-Mental-State Examination (MMSE)

    Time frame: Immediately post treatment (at 2 weeks)

    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).

  4. Mini-Mental-State Examination (MMSE)

    Time frame: 1 month after treatment (at 6 weeks)

    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).

  5. Mini-Mental-State Examination (MMSE)

    Time frame: 3 months after treatment (at 14 weeks)

    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).

  6. Clock Drawing Test (CDT)

    Time frame: Immediately post treatment (at 2 weeks)

    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).

  7. Clock Drawing Test (CDT)

    Time frame: 1 month after treatment (at 6 weeks)

    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).

  8. Clock Drawing Test (CDT)

    Time frame: 3 months after treatment (at 14 weeks)

    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).

  9. Beck Depression Inventory (BDI)

    Time frame: Immediately post treatment (at 2 weeks)

    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).

  10. Beck Depression Inventory (BDI)

    Time frame: 1 month after treatment (at 6 weeks)

    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).

  11. Beck Depression Inventory (BDI)

    Time frame: 3 months after treatment (at 14 weeks)

    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).

  12. Geriatric Depression Scale - short form (GDS-15)

    Time frame: Immediately post treatment (at 2 weeks)

    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).

  13. Geriatric Depression Scale - short form (GDS-15)

    Time frame: 1 month after treatment (at 6 weeks)

    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).

  14. Geriatric Depression Scale - short form (GDS-15)

    Time frame: 3 months after treatment (at 14 weeks)

    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).

Sponsors and collaborators

Lead sponsor

Storz Medical AG

Industry

Collaborators

  • Rheintalklinik

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2020
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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