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| Name | Class |
|---|---|
| Rheintalklinik | UNKNOWN |
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This is a prospective open comprehensive proof-of-principle pilot 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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEUROLITH | Device | transcranial pulse stimulation (TPS) |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henning Lohse-Busch, MD | Rheintalklinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheintalklinik | Bad Krozingen | Baden-Wurttemberg | 79189 | Germany |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 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) |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |