Phase Locked TRanscranial Electrical EXcitation

NCT ID: NCT05847829

Last Updated: 2023-09-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2023-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Novel Method for Transcranial Brain Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Intervention

The study is open label all participants get the same intervention

Group Type EXPERIMENTAL

T-REEX algorithm

Intervention Type DEVICE

Phase locked transcranial stimulation.

Interventions

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T-REEX algorithm

Phase locked transcranial stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stichting Kempenhaeghe

UNKNOWN

Sponsor Role collaborator

Stichting IMEC-NL

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raf van Hoof, PhD

Role: PRINCIPAL_INVESTIGATOR

Stichting Kempenhaeghe

Locations

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Stichting Kempenhaeghe

Heeze, North Brabant, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Raf van Hoof, PhD

Role: CONTACT

0031 40 227 92 04

Hans van Dijk, PhD

Role: CONTACT

0031 40 227 92 04

Facility Contacts

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Raf van Hoof, PhD

Role: primary

00 31 40 227 92 04

Other Identifiers

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NL82733.015.22

Identifier Type: -

Identifier Source: org_study_id

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