Closed-loop tES-non-invasive 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

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

Treatments tested in this trial

  • Transcranial low intensity focused ultrasound (FUS)
  • transcranial electrical stimulation
  • Magnetic Resonance Imaging

Treatment groups

30 Participants
are divided into 4 treatment groups

Sponsors and collaborators