- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05847829
Phase Locked TRanscranial Electrical EXcitation (T-REEX)
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raf van Hoof, PhD
- Phone Number: 0031 40 227 92 04
- Email: HoofR@kempenhaeghe.nl
Study Contact Backup
- Name: Hans van Dijk, PhD
- Phone Number: 0031 40 227 92 04
- Email: DijkH@kempenhaeghe.nl
Study Locations
-
-
Noord Brabant
-
Heeze, Noord Brabant, Netherlands, 5591VE
- Recruiting
- Stichting Kempenhaeghe
-
Contact:
- Raf van Hoof, PhD
- Phone Number: 00 31 40 227 92 04
- Email: HoofR@kempenhaeghe.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Raf van Hoof, PhD, Stichting Kempenhaeghe
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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