Phase Locked TRanscranial Electrical EXcitation
T-REEX
T-REEX: Phase Locked TRanscranial Electrical EXcitation
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedStudy Start
First participant enrolled
June 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedSeptember 5, 2023
September 1, 2023
4 months
November 25, 2022
September 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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
Study Arms (1)
Intervention
EXPERIMENTALThe study is open label all participants get the same intervention
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Age between 18 and 64
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stichting IMEC-NLlead
- Stichting Kempenhaeghecollaborator
Study Sites (1)
Stichting Kempenhaeghe
Heeze, North Brabant, 5591VE, Netherlands
Study Officials
- PRINCIPAL INVESTIGATOR
Raf van Hoof, PhD
Stichting Kempenhaeghe
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2022
First Posted
May 8, 2023
Study Start
June 10, 2023
Primary Completion
October 1, 2023
Study Completion
November 1, 2023
Last Updated
September 5, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share