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Evaluate the Safety and Feasibility of tACS With the Miamind Neurostimulator in Healthy Participants

NCT05999916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-08-06

No results posted yet for this study

Summary

The present study aims to assess the safety and feasibility of repeated transcranial alternating current stimulation (tACS) by the Miamind Neurostimulator in a cohort of healthy participants. Based on the findings of this investigation, subsequent clinical trials assessing the efficiency of tACS by the Miamind Neurostimulator for treatment of Alzheimer's Disease will be conducted.

Conditions

  • Healthy Participants
  • Healthy Population

Interventions

DEVICE

Personalized Miamind Neurostimulator

60 min. 40 Hz max. 1mA / electrode \& total of max. 2 mA across all electrodes. 30- s ramp-up personalised intervention based on individual modelling of electric field distribution to maximise therapeutic effect in the target region. Three target regions, consecutively stimulated (20min each).

Sponsors & Collaborators

  • Hemex AG

    collaborator INDUSTRY

  • Bottneuro AG

    lead INDUSTRY

Principal Investigators

  • Alois Hopf, PhD · Bottneuro AG

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2024-03-22
Completion
2024-03-22

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999916 on ClinicalTrials.gov