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Closed-loop tES-non-invasive Stimulation

ConditionClosed-loop Brain Stimulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Nottingham

About this trial

The goal of this study is to establish if non-invasive closed-loop neuromodulation is an effective approach to enhance cognitive function in healthy 18-40 years old volunteers. The main questions it aims to answer are:

* Can closed-loop stimulation increase stimulation effectiveness? * Can closed-loop focused ultrasound specifically engage with excitatory or inhibitory neural populations in the target structure as measured through MRS? * Can observed stimulation outcomes for FUS be predicted through connectome analysis and computational models of indirect changes?

Researchers will compare different closed-loop options to their open-loop counterpart to see if closed-loop approaches can increase efficacy and reduce the variability of the stimulation compared to open-loop approaches.

Participants will:

* Answer some questionnaires at the start of the study and after each intervention session. * Undertake a MRI scanning session. * Undertake one open-loop FUS session. * Undertake one tES session. * Undertake one closed-loop FUS sessions involving tES and FUS, followed by a MRI scanning * Undertake one sham FUS session * Attend one visit in person to assess eligibility through questionnaires and one cognitive task

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant is willing and able to give informed consent for participation in the study

Aged between 18 and 40

Good general health

Not consume alcohol 48 hours prior study visit

Disqualifiers

Inability to complete MRI/FUS/TMS/tES safety questionnaire and / or informed consent process.

Current or previous diagnosis of a neurological, neurosurgical, psychiatric disorders.

Other significant medical condition (specific details to be reviewed by the CI prior to inclusion).

Currently pregnant, breast feeding, or on planned pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial low intensity focused ultrasound (FUS)

    Other intervention

    Low intensity focused ultrasound stimulation (FUS) with 500kHz transducer for following either the continuous theta burst or intermittent theta burst protocol using the NeuroFus PRO system

  • transcranial electrical stimulation

    Other intervention

    Transcranial electrical stimulation (by means of transcranial alternating current stimulation (tACS) or non-invasive temporal interference (TI) electrical stimulation) using the DS5 isolated bipolar constant current stimulator together connected to a wave generator and with two electrodes for tACS (TI implementation will be carried out with two DS5 systems, separate wave generators and four electrodes).

  • Magnetic Resonance Imaging

    Procedure/Surgery

    We obtain baseline functional, metabolic and structural information through MRI and MRS scanning

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: Open-loop transcranial low-intensity FUSActive comparator 2 interventions
Group B: Closed-loop transcranial low-intensity FUSExperimental treatment 3 interventions
Group C: tES aloneActive comparator 2 interventions
Group D: Sham FUSActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in EEG Power in Alpha Band (8-12Hz)

Time frame
Baseline to 10 weeks, measured immediately before, during, and immediately after stimulation
2

Change from Baseline in EEG Power in Theta Band (4-7Hz)

Time frame
Baseline to 10 weeks, measured immediately before, during, and immediately after stimulation
3

Change from Baseline in EEG Power in Beta Band (13-30Hz)

Time frame
Baseline to 10 weeks, measured immediately before, during, and immediately after stimulation
4

Change from Baseline in EEG Power in Gamma Band (31-45Hz)

Time frame
Baseline to 10 weeks, measured immediately before, during, and immediately after stimulation

Secondary outcomes

1

Structured questionnaire assessing adverse effects of the intervention

Time frame
Immediately after stimulation, 24 hours after stimulation and 1 week after stimulation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: