Novel Method for Transcranial Brain StimulationT-REEXNCT05847829
Phase Locked TRanscranial Electrical EXcitation
A study testing T-REEX algorithm in people with Novel Method for Transcranial Brain Stimulation, run by Stichting IMEC-NL at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Novel Method for Transcranial Brain Stimulation
- What is being tested?
- T-REEX algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jun 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Age between 18 and 64
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Stichting Kempenhaeghe
Heeze, North Brabant, 5591VE
Raf van Hoof, PhD, 00 31 40 227 92 04, HoofR@kempenhaeghe.nl
About this study
Official title: 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.
- Being tested
- T-REEX algorithm
- Keywords
- Brain stimulation, Closed-loop, Brain activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-REEX algorithmDevice
Phase locked transcranial stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The study is open label all participants get the same intervention Receives: Device: T-REEX algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start10 Jun 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel Method for Transcranial Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stichting IMEC-NL
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Kempenhaeghe
- Responsible party
- Sponsor
- Investigators
- Raf van Hoof, PhD, Principal investigator, Stichting Kempenhaeghe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847829
- Sponsor's protocol ID
- NL82733.015.22
- Acronym
- T-REEX
- Status last verified
- Sep 2023
- First submitted
- 25 Nov 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-REEX: Phase Locked TRanscranial Electrical EXcitation
- ClinicalTrials.gov ID
- NCT05847829
- Acronym / sponsor ID
- T-REEX / NL82733.015.22
- Keywords
- Brain stimulation, Closed-loop, Brain activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stichting IMEC-NLUniversity, hospital or other
- Collaborators
- Stichting Kempenhaeghe
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: T-REEX algorithmThe study is open label all participants get the same intervention |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Age between 18 and 64
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-REEX algorithmPhase locked transcranial stimulation. | Device | Intervention |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Novel Method for Transcranial Brain Stimulation
Not yet recruiting
Efficacy of kTMP, a Novel Non-invasive Brain Stimulation Method, for the Treatment of Anhedonia
Anhedonia, Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raf van Hoof, PhD principal investigator
Stichting Kempenhaeghe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-REEX algorithm in people with Novel Method for Transcranial Brain Stimulation, run by Stichting IMEC-NL at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raf van Hoof, PhD (0031 40 227 92 04, HoofR@kempenhaeghe.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.