Traumatic Brain InjuryNCT07271524
Non-invasive Deep Brain Stimulation to Improve Spatial Navigation Abilities in Individuals Following Traumatic Brain Injury
A study testing Transcranial electric stimulation in people with Traumatic Brain Injury, run by Friedhelm Hummel at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Transcranial electric stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Clinical diagnosis of TBI
- No history of other severe neurological or psychiatric disorders
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
EPFL, Campus Biotech
Geneva, Canton of Geneva, 1202
Friedhelm Hummel, +41 27 603 23 59, friedhelm.hummel@epfl.ch
EPFL Valais, Clinique Romande de readaptation
Sion, Valais, 1950
Friedhelm Hummel, +41 27 603 23 59, friedhelm.hummel@epfl.ch
About this study
Official title: Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Transcranial electric stimulation
- Keywords
- non-invasive brain stimulation, deep brain stimulation, subcortical, memory, neuro-imaging, transcranial temporal interference stimulation, spatial navigation, electroencephalography, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial electric stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Patterned stimulation (intermittent theta-burst) generating temporal interference in the hippocampal-entorhinal complex; see Beanato et al. 2024, Sci Adv (DOI: 10.1126/sciadv.ado4103) for details. Receives: Other: Transcranial electric stimulation |
| Control stimulation | Placebo comparator | High-frequency (2kHz) electrical stimulation with no frequency shift, generating no temporal interference. Receives: Other: Transcranial electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)
Accuracy in the spatial navigation task
Accuracy (error, in virtual meters, between correct and recalled object location) in the virtual reality spatial navigation task.
Measured: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)
Secondary outcomes (2)
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.
Measured: Peri-interventional (up to 1 hour; approximate duration of intervention = 40 minutes, administered in a single session)
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.
Measured: Baseline (before the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friedhelm Hummel
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Bertarelli, The Novartis Foundation, Clinique Romande de Readaptation, University of Guadalajara, Swiss National Science Foundation, Wyss Center for Bio and Neuroengineering, Fondation Akiva, Canton du Valais
- Responsible party
- Sponsor-investigator, Friedhelm Hummel, Ecole Polytechnique Fédérale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271524
- Sponsor's protocol ID
- 2020-00127-wp73t
- Other IDs
- 2020-00127
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)
- ClinicalTrials.gov ID
- NCT07271524
- Acronym / sponsor ID
- 2020-00127-wp73t
- Conditions
- Traumatic Brain Injury
- Keywords
- non-invasive brain stimulation, deep brain stimulation, subcortical, memory, neuro-imaging, transcranial temporal interference stimulation, spatial navigation, electroencephalography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Friedhelm HummelUniversity, hospital or other
- Collaborators
- Fondation Bertarelli, The Novartis Foundation, Clinique Romande de Readaptation, University of Guadalajara, Swiss National Science Foundation, Wyss Center for Bio and Neuroengineering, Fondation Akiva, Canton du Valais
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Other: Transcranial electric stimulationPatterned stimulation (intermittent theta-burst) generating temporal interference in the hippocampal-entorhinal complex; see Beanato et al. 2024, Sci Adv (DOI: 10.1126/sciadv.ado4103) for details. |
| Control stimulation | Placebo comparator | Other: Transcranial electric stimulationHigh-frequency (2kHz) electrical stimulation with no frequency shift, generating no temporal interference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Clinical diagnosis of TBI
- No history of other severe neurological or psychiatric disorders
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial electric stimulationTranscranial 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. | Other | Active stimulation, Control stimulation |
Primary outcome
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.
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
EPFL Valais, Clinique Romande de readaptation
Sion, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial electric stimulation in people with Traumatic Brain Injury, run by Friedhelm Hummel at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed in the spatial navigation task (time frame: During intervention (approximate duration of intervention = 40 minutes, administered in a single session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.