Phase Locked TRanscranial Electrical EXcitation (T-REEX)

September 1, 2023 updated by: Stichting IMEC-NL

T-REEX: Phase Locked TRanscranial Electrical EXcitation

Transcranial current stimulation (tCS) has been extensively studied due to its potential of selectively stimulate brain regions in a non-invasive way. However, classic stimulation paradigms are often applied in an open loop configuration, without considering the effects on the underlying brain activity.

Recent studies suggest that when alternating current are used, it would be beneficial to phase lock the stimulation to the target brain wave of interest to achieve selective temporal stimulation, allowing for better control over the stimulation effects.

This study aims at demonstrating a novel setup that allows for precise stimulation targeted in space and time. To achieve that, a combination of tCS and (EEG phased locked) closed-loop modality are used to obtain the required selectivity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Noord Brabant
      • Heeze, Noord Brabant, Netherlands, 5591VE
        • Recruiting
        • Stichting Kempenhaeghe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Signed informed consent
  • Age between 18 and 64

Exclusion Criteria:

  • Wounded or particular sensitive skin at areas of investigation. For example, skinrash, discoloration, scars, or open wounds
  • Allergies to adhesive or dry electrodes or silver chloride
  • Pregnant or lactating
  • Any of the following symptoms (fever, tiredness, dry cough, aches and pains, nasal congestion, runny nose, sore throat, diarrhoea)
  • Known neurological disorders
  • Previous epileptic episodes
  • Active implants such as pacemakers or brain stimulators
  • Intracranial metal implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The study is open label all participants get the same intervention
Device: T-REEX algorithm
Phase locked transcranial stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The phase difference (error) between the estimated phase of EEG activity and the phase of the delivered stimulation at the target locationor EEG readout and tCS stimulation
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
the amount of phase and/or amplitude change in the brain wave of interest (e.g., 10 Hz alpha activity) resulting from different tCS modalities and stimulation parameters used
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stichting IMEC-NL

Collaborators

Stichting Kempenhaeghe

Investigators

  • Principal Investigator: Raf van Hoof, PhD, Stichting Kempenhaeghe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

November 25, 2022

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL82733.015.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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