German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation

ConditionAlzheimer Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-85

SponsorHeinrich-Heine University, Duesseldorf

About this trial

This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

AD Patients undergoing TPS

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Registry
Diagnostic test
Clinical data collection of patients scheduled for on-label treatment

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Patients with Clinical Alzheimer's syndrome treated with TPS1 intervention

Trial outcomes

Primary outcomes

Number of (Serious) Adverse Events

Number of adverse events (without causal relationship to therapy) AE, SAE (query after the first 6-cycle block and before each booster) scaling according to NRS (1-10) for each ADE (query before each stimulation)

Time frame

through study completion, an average of 1 year

Number of adverse device effects

Number of ADEs and (U)SADEs scaling according to NRS (1-10) for each ADE (query before each stimulation)

Time frame

through study completion, an average of 1 year

Secondary outcomes

ADAS

Alzheimer's Disease Asessment Scale (ADAS) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)

Time frame

Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

Mini Mental State Examination (MMSE) baseline and follow- up

Mini Mental State Examination (MMSE) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)

Time frame

Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

BDI-II

BDI-II baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)

Time frame

Baseline, post first 6 sessions and after 3, 6, 9 and 12 months

Clinical Dementia Rating Sum of Boxes Score (CDR-SB)

Clinical Dementia Rating Sum of Boxes Score (CDR-SB) baseline and post 6 sessions as well as after 3, 6, 9 and 12 months (desired but not mandatory, collected within 3 days after stimulation)

Time frame

Baseline, post first 6 sessions and after 3, 6, 9 and 12 months