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T-REEX: Phase Locked TRanscranial Electrical EXcitation

Sponsor
Stichting IMEC-NL (Other)
Overall Status
Recruiting
CT.gov ID
NCT05847829
Collaborator
Stichting Kempenhaeghe (Other)
10
Enrollment
1
Location
1
Arm
2.8
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: T-REEX algorithm
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
T-REEX: Phase Locked TRanscranial Electrical EXcitation
Anticipated Study Start Date :
May 8, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

The study is open label all participants get the same intervention

Device: T-REEX algorithm
Phase locked transcranial stimulation.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stichting Kempenhaeghe Heeze Noord Brabant Netherlands 5591VE

Sponsors and Collaborators

  • Stichting IMEC-NL
  • Stichting Kempenhaeghe

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stichting IMEC-NL
ClinicalTrials.gov Identifier:
NCT05847829
Other Study ID Numbers:
  • NL82733.015.22
First Posted:
May 8, 2023
Last Update Posted:
May 8, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Stichting IMEC-NL
Brain stimulation
Closed-loop
Brain activity

Study Results

No Results Posted as of May 8, 2023