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NCT Number: NCT07271524

Non-invasive Deep Brain Stimulation to Improve Spatial Navigation Abilities in Individuals Following Traumatic Brain Injury

Impairments in spatial memory and spatial navigation are commonly reported amongst patients presenting post-traumatic brain injury (TBI). In this study, the investigators examine the effect of non-invasive deep brain stimulation of the hippocampal-entorhinal complex (HC-EC), a key region supporting navigation abilities, on spatial navigation performance in TBI patients. Using a virtual reality task where participants must first encode and later recall the location of objects in a virtual arena, the investigators contrast performance while active versus control stimulation is applied to the HC-EC. The investigators additionally record brain activity using electroencephalography (EEG) prior to, during, and after task performance to characterize the neural correlates of spatial navigation abilities in TBI patients, and how they are affected by stimulation.

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Key information

Conditions

Traumatic Brain Injury Behavior Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Spatial Behavior Spatial Navigation Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EPFL, Campus Biotech, Geneva, Canton of Geneva, Switzerland

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About this study

Patients will perform a virtual reality spatial navigation task comparable to that used previously by Beanato and colleagues (2024; DOI: 10.1126/sciadv.ado4103). Patients will perform 4 blocks of task, each lasting approximately 10 minutes; during the full duration of each block, either active or control transcranial temporal interference stimulation (tTIS) will be applied in an interleaved manner, and EEG recordings will be collected. Resting-state EEG recordings will also be collected prior to and following task performance.

Structural, diffusion-weighted, and resting-state MRI scans will additionally be performed during a prior baseline session.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Clinical diagnosis of TBI
  • No history of other severe neurological or psychiatric disorders

Exclusion criteria

  • Unable to consent
  • Severe neuropsychiatric (e.g., major depression, severe dementia) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life threatening infectious diseases)
  • Severe sensory or cognitive impairment or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the experimental tasks
  • Inability to follow or non-compliance with the procedures of the study
  • Contraindications for NIBS or MRI:
  • Electronic or ferromagnetic medical implants/device, non-MRI compatible metal implant
  • History of seizures
  • Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics
  • Regular use of narcotic drugs
  • Pregnancy
  • Request of not being informed in case of incidental findings
  • Concomitant participation in another trial involving probing of neuronal plasticity

Treatment and study plan

transcranial electric stimulation

Other

Transcranial temporal interference stimulation (tTIS) is an innovative non-invasive brain stimulation approach, in which two or more independent stimulation channels deliver high-frequency currents in the kHz range (oscillating at f1 and f1 + Δf). These high-frequency currents are assumed to be too high to effectively modulate neuronal activity. Still, by applying a small shift in frequency, they result in a modulated electric field with the envelope oscillating at the low-frequency Δf (target frequency) where the two currents overlap. The peak of the modulated envelope amplitude can be steered towards specific areas located deep in the brain, by tuning the positions of the electrodes and the current ratio across stimulation channels. Here, the investigators apply tTIS via surface electrodes applying a low-intensity, sub-threshold protocol following the safety guidelines for low-intensity transcranial electric stimulation in humans.

Primary outcomes

  1. Speed in the spatial navigation task

    Time frame: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)

    Participant speed (in seconds) of departure to, and reach of, object location in the virtual reality spatial navigation task.

  2. Accuracy in the spatial navigation task

    Time frame: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)

    Accuracy (error, in virtual meters, between correct and recalled object location) in the virtual reality spatial navigation task.

Secondary outcomes

  1. Brain oscillatory activity

    Time frame: Peri-interventional (up to 1 hour; approximate duration of intervention = 40 minutes, administered in a single session)

    Resting-state and task-related EEG recordings are collected, and metrics of oscillatory activity are extracted to characterize the neural activity associated to the primary outcome.

  2. Brain structure and connectivity

    Time frame: Baseline (before the intervention)

    Structural, diffusion-weighted, and resting-state MRI scans are performed during the baseline session and are used to evaluate inter-individual anatomical factors associated to the primary outcome.

Other outcomes

  1. Age (years)

    Time frame: Baseline (before the intervention)

    Participant age will be recorded to examine its influence on individual responsiveness to the intervention.

  2. Montreal Cognitive Assessment questionnaire score

    Time frame: Baseline (before the intervention)

    Participant score on the Montreal Cognitive Assessment questionnaire will be collected to examine its influence on individual responsiveness to the intervention.

  3. Frontal Assessment Battery questionnaire score

    Time frame: Baseline (before the intervention)

    Participant score in the Frontal Assessment Battery questionnaire will be collected to examine its influence on individual responsiveness to the intervention.

Sponsors and collaborators

Lead sponsor

Friedhelm Hummel

Other

Collaborators

  • Canton du Valais
  • Clinique Romande de Readaptation
  • Fondation Akiva
  • Fondation Bertarelli
  • Swiss National Science Foundation
  • The Novartis Foundation
  • University of Guadalajara
  • Wyss Center for Bio and Neuroengineering

Registry information

Official study title

Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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