Brain Stimulation for Neurological Patients

NCT ID: NCT03770182

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-07-27

Brief Summary

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This is a prospective double-blind randomized placebo-controlled crossover clinical trial

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

NEUROLITH

* Cycle 1: Active treatment
* Cycle 2: Sham treatment

Group Type EXPERIMENTAL

NEUROLITH

Intervention Type DEVICE

transcranial pulse stimulation (TPS)

Group B

NEUROLITH

* Cycle 1: Sham treatment
* Cycle 2: Active treatment

Group Type EXPERIMENTAL

NEUROLITH

Intervention Type DEVICE

transcranial pulse stimulation (TPS)

Interventions

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NEUROLITH

transcranial pulse stimulation (TPS)

Intervention Type DEVICE

Other Intervention Names

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transcranial pulse stimulation TPS

Eligibility Criteria

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Inclusion Criteria

* Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
* At least 3 months of stable antidementive therapy or no antidementive therapy necessary
* Signed written informed consent
* Monthly pregnancy test for women in childbearing years
* Age \>= 18 years

Exclusion Criteria

* Non-compliance with the protocol
* Pregnant or breastfeeding women
* Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain tumor)
* Hemophilia or other blood clotting disorders
* Cortisone treatment within the last 6 weeks before first treatment
* Thrombosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role collaborator

Storz Medical AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Beisteiner, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Reference Type DERIVED
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Other Identifiers

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TPS-AD-Vienna

Identifier Type: -

Identifier Source: org_study_id