Non-invasive Deep Brain Stimulation to Improve Spatial Navigation Abilities in Individuals Following Traumatic Brain Injury
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial electric stimulation.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)
Overview
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.
Detailed description
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.
Interventions
- Other Transcranial electric stimulation
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 f
Primary outcome measures
- Speed in the spatial navigation task [Time frame: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)]
- Accuracy in the spatial navigation task [Time frame: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)]
Secondary outcome measures (2)
- Brain oscillatory activity [Time frame: Peri-interventional (up to 1 hour; approximate duration of intervention = 40 minutes, administered in a single session)]
- Brain structure and connectivity [Time frame: Baseline (before the intervention)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Switzerland · 2 centers
- EPFL, Campus Biotech — Geneva
- EPFL Valais, Clinique Romande de readaptation — Sion
Identifiers
NCT: NCT07271524 · 2020-00127-wp73t · 2020-00127