NCT04333329

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

September 6, 2018

Last Update Submit

April 1, 2020

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

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

    Immediately post treatment (at 2 weeks)

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

    1 month after treatment (at 6 weeks)

  • Mini-Mental-State Examination (MMSE)

    Immediately post treatment (at 2 weeks)

  • Mini-Mental-State Examination (MMSE)

    1 month after treatment (at 6 weeks)

  • Mini-Mental-State Examination (MMSE)

    3 months after treatment (at 14 weeks)

  • +9 more secondary outcomes

Study Arms (1)

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

Device: NEUROLITH

Interventions

NEUROLITHDEVICE

transcranial pulse stimulation (TPS)

Also known as: transcranial pulse stimulation (TPS)
AD Patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years ≤ Age ≤ 85 years
  • Monthly pregnancy tests for female patients in childbearing age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheintalklinik

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Henning Lohse-Busch, MD

    Rheintalklinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2018

First Posted

April 3, 2020

Study Start

August 8, 2015

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)