Phase Locked TRanscranial Electrical EXcitation

Not Applicable

Recruiting

• Conditions: Novel Method for Transcranial Brain Stimulation
• Interventions: Device: T-REEX algorithm

• Registration Number: NCT05847829
• Lead Sponsor: Stichting IMEC-NL

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-11-25
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-08
• Study Start: 2023-06-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	T-REEX algorithm	The study is open label all participants get the same intervention

Primary Outcome Measures

Name	Time	Method
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	2 hours

Secondary Outcome Measures

Name	Time	Method
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	2 hours

Trial Locations

Locations (1)

Stichting Kempenhaeghe; 🇳🇱 Heeze, Noord Brabant, Netherlands