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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFriedhelm Hummel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Clinical diagnosis of TBI

No history of other severe neurological or psychiatric disorders

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Transcranial electric stimulation

    Other intervention

    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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Active stimulationExperimental treatment 1 intervention
Group B: Control stimulationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Speed in the spatial navigation task

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

Time frame
During intervention (approximate duration of intervention = 40 minutes, administered in a single session)
2

Accuracy in the spatial navigation task

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

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

Secondary outcomes

1

Brain oscillatory activity

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.

Time frame
Peri-interventional (up to 1 hour; approximate duration of intervention = 40 minutes, administered in a single session)
2

Brain structure and connectivity

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.

Time frame
Baseline (before the intervention)

Other outcomes

1

Age (years)

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

Time frame
Baseline (before the intervention)
2

Montreal Cognitive Assessment questionnaire score

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

Time frame
Baseline (before the intervention)
3

Frontal Assessment Battery questionnaire score

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

Time frame
Baseline (before the intervention)

Sponsors and contacts

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

Friedhelm Hummel

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Sponsor institution

Fondation Bertarelli

Collaborator

The Novartis Foundation

Collaborator

Clinique Romande de Readaptation

Collaborator

University of Guadalajara

Collaborator

Swiss National Science Foundation

Collaborator

Wyss Center for Bio and Neuroengineering

Collaborator

Fondation Akiva

Collaborator

Canton du Valais

Collaborator

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