MedTrace Logo

Closed-loop tES-non-invasive Stimulation

NCT07671079 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-26

No results posted yet for this study

Summary

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

Conditions

  • Closed-loop Brain Stimulation

Interventions

OTHER

Transcranial low intensity focused ultrasound (FUS)

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

OTHER

transcranial electrical stimulation

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).

PROCEDURE

Magnetic Resonance Imaging

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

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Marcus Kaiser, PhD · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-08-31
Completion
2027-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07671079 on ClinicalTrials.gov