StrokeANOSONCT04845529
Improving Awareness for Spatial Neglect With tDCS
A study testing transcranial direct current stimulation (tDCS) in people with Stroke and Anosognosia, run by University of Geneva, Switzerland.
Trial summary
Brain-damaged patients can show severe neurological and cognitive deficits, and yet often remain strikingly unaware of these symptoms: this condition is called anosognosia. The aim of this study is to improve awareness in right-brain-damaged patients with Unilateral Spatial Neglect (USN) following stroke using… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke, Anosognosia, Neglect, Hemispatial
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jan 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke affecting the right-hemisphere
- Presence of USN, as assessed by a standard neuropsychological evaluation
- Structural images of the brain lesion available (magnetic resonance or tomographic scans)
- Criteria for electrical brain stimulation
- Good (or corrected) visual acuity
- High proficiency in French
- Right-handed
Who cannot join
- Presence of general cognitive deficits and/or suspicious of possible cognitive deficits
- Presence of difficulty in task's comprehension
- Impossibility to sustain a research session of at least 45minutes (e.g., attentional lability)
- Precedent additional neurological disorder and/or current or precedent psychiatric disease
- Presence of one or more exclusion criteria for the electrical brain stimulation 18, as following:
- Presence (or suspected presence) of metal in the brain or skull or body (except titanium) (e.g. splinters, fragments, clips, etc.) Presence of cochlear implants, implanted neuro-stimulator (e.g., DBS, epidural/subdural, VNS), cardiac pacemaker, medication infusion device, spinal or ventricular derivations Presence of epilepsy (participant and/or the close family) and/or precedent epileptic seizures (participant) Presence of a fainting spell or syncope, due to neurological diseases (not consider syncope during blood sampling or after being in a warm environment or after emotionally stressful events) Presence of a severe (i.e., followed by loss of consciousness) head trauma Presence of hearing problems or ringing in your ears (e.g. tinnitus) Current treatment under psychoactive (e.g. antidepressants, tranquilizers) or antiepileptic medications Chronic headache For women: you are pregnant or there is any chance that you might be.
About this study
Official title: Improving Awareness in Right-brain-damaged Patients With Unilateral Spatial Neglect Using Transcranial Direct Current Stimulation (tDCS)
Brain-damaged patients can show severe neurological and cognitive deficits, and yet often remain strikingly unaware of these symptoms: this condition is called anosognosia. The aim of this study is to improve awareness in right-brain-damaged patients with Unilateral Spatial Neglect (USN) following stroke using transcranial direct current stimulation (tDCS). tDCS is a neuromodulatory technique that delivers low-intensity current to the brain facilitating (anodal tDCS) or inhibiting (cathodal tDCS) spontaneous neuronal activity. tDCS does not induce activity in resting neuronal networks, but modulates spontaneous neuronal activity: consequently, the amount and direction of effects critically depend on the previous state of the neural structures.
We will test USN patients showing anosognosia for neglect symptoms. Different brain areas will be stimulated, to target explicit and implicit components of anosognosia, including parietal and frontal brain regions.
Read the detailed description
The aim of this study is to improve awareness in right-brain-damaged patients with USN following stroke using transcranial direct current stimulation (tDCS). tDCS is a neuromodulatory technique that delivers a low-intensity direct current (e.g., 1-2 mA) to cortical areas facilitating (anodal tDCS) or inhibiting (cathodal tDCS) spontaneous neuronal activity. This stimulation is delivered by a stimulation device with two (or, rarely, more) electrodes placed on the scalp. The electrode assembly most commonly used for tDCS comprises (1) a conductive rubber electrode, (2) an electrode sponge, and (3) an electrolyte-based contact medium (e.g., saline, gel, or conductive cream) to facilitate delivery of current to the scalp, as well as (4) any materials used to shape these components or otherwise direct current flow (plastic casing, rivets). The tDCS mechanism of action is a subthreshold modulation of neuronal membrane potentials, which alters cortical excitability and activity dependent on the current flow direction through the target neurons. tDCS does not induce activity in resting neuronal networks, but modulates spontaneous neuronal activity: consequently, the amount and direction of effects critically depend on the previous physiological state of the target neural structures. In this sense, tDCS represents a neuromodulatory technique which do not induce massive synchronized discharge of action potentials as the Transcranial Magnetic Stimulation.
The introduction of tDCS in the clinical context took place about 15 years ago. Seminal studies demonstrated that weak, direct electric currents could be delivered effectively transcranially: specifically, anodal direct current stimulation was shown to increase cortical excitability, whereas cathodal stimulation decreased it. tDCS has been tested in thousands of subjects world-wide with no evidence of important side effects. For instance, it has been used in healthy individuals to change the efficacy of various motor and cognitive processes, with only mild and transient effects such as tingling and itching sensation under the stimulation electrode, moderate fatigue and headache. Moreover, since it is well-tolerated also in patients, a growing body of evidence is focused on the use of tDCS in clinical context for rehabilitative purposes: after brain damage, the induction of enhancement of the damaged hemisphere through anodal tDCS is effective in reducing the cognitive deficits caused by the lesion (e.g., stimulating perilesional areas).
We will select USN patients, showing anosognosia for neglect symptoms, from a previous study. If only a few patients will accept to participate in this protocol, new right-brain-damaged patients will be recruited at HUG.
A protocol using anodal tDCS (i.e., excitatory stimulation) will be administered. We will target brain areas that could be involved in anosognosia for USN and, if these sites are damaged by the lesion, perilesional unimpaired regions will be stimulated, as the rationale is that excitatory stimulation of these sites can restore the defective error monitoring, and temporarily ameliorate anosognosia.
Before and immediately after each stimulation, the three measures of anosognosia (i.e., explicit self-rating, SCR and EEG error-related potentials) will be recorded: this procedure has been chosen in order to compare the tDCS effects on the different features of anosognosia. To control for the size of the parietal and frontal damage, which could influence the beneficial effect of tDCS, we will estimate the number of voxels damaged in these regions through the lesion maps of patients.
Each one of the three experimental sessions is expected to last no more than 2h30min. This includes: 15/20min to welcome the participant, explaining the experiment and make him sign the informed consent and the screening criteria for tDCS ; 30min of neuropsychological screening (only for patients who did not undergo Study 1 or only for the first session); 20min of preparation of the set-up (connecting the cables for SCR, placing the EEG cap and connecting all the electrodes, installing the tDCS electrodes); 60min for the experiment's recording (anosognosia + tDCS + anosognosia); 10/15min for cleaning up the set up and doing a short debriefing with the participant.
- Conditions
- Stroke, Anosognosia, Neglect, Hemispatial
- Being tested
- transcranial direct current stimulation (tDCS)
- Keywords
- Brain modulation, Recovery, Implicit and explicit anosognosia
- Medical subject headings
- Stroke, Agnosia, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
We will apply tDCS to the patients' brains for 20 minutes at the intensity of 1.5mA. Each patient will undergo the three sessions (separated by at least 24h to minimize carry-over effects), in a pseudo-randomized order across patients.
| Study group | Role | What they receive |
|---|---|---|
| 1 tDCS Parietal | Experimental | Anodal tDCS applied to the right inferior parietal cortex Receives: Device: transcranial direct current stimulation (tDCS) |
| 2 tDCS Frontal | Experimental | Anodal tDCS applied to the medial frontal cortex Receives: Device: transcranial direct current stimulation (tDCS) |
| 3 Sham | Sham comparator | Sham tDCS (control, no stimulation delivered). Following a standard sham protocol, in this condition the tDCS will be active the first 30seconds and the last 30seconds of the session, but silent during the other 19minutes Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-rating about anosognosia for USN
We will use a vertical visual scale on a monitor, where the patients should evaluate their performance after each trial of a neglect task.
Measured: from Baseline to 30 minutes
Change in implicit measures of anosognosia for USN
Each self-rating will be time-locked with the brain activity of participants in order to record the so-called error-related potentials. Averaged evoked potentials for each domain of awareness will be computed, and a baseline correction will be applied to the epochs. The first error-related component (ERN) will be determined as the mean amplitude in the time window from 60 ms to 140 ms post-response onset; the second component of interest (Pe) will be determined as the mean amplitude in the time-window from 200 ms and 600 ms post-response onset.
Measured: from Baseline to 30 minutes
Secondary outcomes (1)
Lesion correlate of recovery of anosognosia for USN
We will correlate the presence/absence of effective modulation of anosognosia for USN to the damage in specific brain regions.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startDec 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Roberta Ronchi, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845529
- Sponsor's protocol ID
- 2017-01749
- Other IDs
- 2017
- Acronym
- ANOSO
- Status last verified
- May 2025
- First submitted
- 30 Mar 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Awareness in Right-brain-damaged Patients With Unilateral Spatial Neglect Using Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT04845529
- Acronym / sponsor ID
- ANOSO / 2017-01749
- Conditions
- Stroke, Anosognosia, Neglect, Hemispatial
- Keywords
- Brain modulation, Recovery, Implicit and explicit anosognosia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Apr 2021 (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.
Brain-damaged patients can show severe neurological and cognitive deficits, and yet often remain strikingly unaware of these symptoms: this condition is called anosognosia. The aim of this study is to improve awareness in right-brain-damaged patients with Unilateral Spatial Neglect (USN) following stroke using transcranial direct current stimulation (tDCS). tDCS is a neuromodulatory technique that delivers low-intensity current to the brain facilitating (anodal tDCS) or inhibiting (cathodal tDCS) spontaneous neuronal activity. tDCS does not induce activity in resting neuronal networks, but modulates spontaneous neuronal activity: consequently, the amount and direction of effects critically depend on the previous state of the neural structures.
We will test USN patients showing anosognosia for neglect symptoms. Different brain areas will be stimulated, to target explicit and implicit components of anosognosia, including parietal and frontal brain regions.
Detailed description
The aim of this study is to improve awareness in right-brain-damaged patients with USN following stroke using transcranial direct current stimulation (tDCS). tDCS is a neuromodulatory technique that delivers a low-intensity direct current (e.g., 1-2 mA) to cortical areas facilitating (anodal tDCS) or inhibiting (cathodal tDCS) spontaneous neuronal activity. This stimulation is delivered by a stimulation device with two (or, rarely, more) electrodes placed on the scalp. The electrode assembly most commonly used for tDCS comprises (1) a conductive rubber electrode, (2) an electrode sponge, and (3) an electrolyte-based contact medium (e.g., saline, gel, or conductive cream) to facilitate delivery of current to the scalp, as well as (4) any materials used to shape these components or otherwise direct current flow (plastic casing, rivets). The tDCS mechanism of action is a subthreshold modulation of neuronal membrane potentials, which alters cortical excitability and activity dependent on the current flow direction through the target neurons. tDCS does not induce activity in resting neuronal networks, but modulates spontaneous neuronal activity: consequently, the amount and direction of effects critically depend on the previous physiological state of the target neural structures. In this sense, tDCS represents a neuromodulatory technique which do not induce massive synchronized discharge of action potentials as the Transcranial Magnetic Stimulation.
The introduction of tDCS in the clinical context took place about 15 years ago. Seminal studies demonstrated that weak, direct electric currents could be delivered effectively transcranially: specifically, anodal direct current stimulation was shown to increase cortical excitability, whereas cathodal stimulation decreased it. tDCS has been tested in thousands of subjects world-wide with no evidence of important side effects. For instance, it has been used in healthy individuals to change the efficacy of various motor and cognitive processes, with only mild and transient effects such as tingling and itching sensation under the stimulation electrode, moderate fatigue and headache. Moreover, since it is well-tolerated also in patients, a growing body of evidence is focused on the use of tDCS in clinical context for rehabilitative purposes: after brain damage, the induction of enhancement of the damaged hemisphere through anodal tDCS is effective in reducing the cognitive deficits caused by the lesion (e.g., stimulating perilesional areas).
We will select USN patients, showing anosognosia for neglect symptoms, from a previous study. If only a few patients will accept to participate in this protocol, new right-brain-damaged patients will be recruited at HUG.
A protocol using anodal tDCS (i.e., excitatory stimulation) will be administered. We will target brain areas that could be involved in anosognosia for USN and, if these sites are damaged by the lesion, perilesional unimpaired regions will be stimulated, as the rationale is that excitatory stimulation of these sites can restore the defective error monitoring, and temporarily ameliorate anosognosia.
Before and immediately after each stimulation, the three measures of anosognosia (i.e., explicit self-rating, SCR and EEG error-related potentials) will be recorded: this procedure has been chosen in order to compare the tDCS effects on the different features of anosognosia. To control for the size of the parietal and frontal damage, which could influence the beneficial effect of tDCS, we will estimate the number of voxels damaged in these regions through the lesion maps of patients.
Each one of the three experimental sessions is expected to last no more than 2h30min. This includes: 15/20min to welcome the participant, explaining the experiment and make him sign the informed consent and the screening criteria for tDCS ; 30min of neuropsychological screening (only for patients who did not undergo Study 1 or only for the first session); 20min of preparation of the set-up (connecting the cables for SCR, placing the EEG cap and connecting all the electrodes, installing the tDCS electrodes); 60min for the experiment's recording (anosognosia + tDCS + anosognosia); 10/15min for cleaning up the set up and doing a short debriefing with the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 tDCS Parietal | Experimental | Device: transcranial direct current stimulation (tDCS)Anodal tDCS applied to the right inferior parietal cortex |
| 2 tDCS Frontal | Experimental | Device: transcranial direct current stimulation (tDCS)Anodal tDCS applied to the medial frontal cortex |
| 3 Sham | Sham comparator | Device: transcranial direct current stimulation (tDCS)Sham tDCS (control, no stimulation delivered). Following a standard sham protocol, in this condition the tDCS will be active the first 30seconds and the last 30seconds of the session, but silent during the other 19minutes |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First stroke affecting the right-hemisphere
- Presence of USN, as assessed by a standard neuropsychological evaluation
- Structural images of the brain lesion available (magnetic resonance or tomographic scans)
- Criteria for electrical brain stimulation
- Good (or corrected) visual acuity
Key exclusion criteria (6 listed)
- Presence of general cognitive deficits and/or suspicious of possible cognitive deficits
- Presence of difficulty in task's comprehension
- Impossibility to sustain a research session of at least 45minutes (e.g., attentional lability)
- Precedent additional neurological disorder and/or current or precedent psychiatric disease
- Presence of one or more exclusion criteria for the electrical brain stimulation 18, as following:
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 direct current stimulation (tDCS)We will apply tDCS to the patients' brains for 20 minutes at the intensity of 1.5mA. Each patient will undergo the three sessions (separated by at least 24h to minimize carry-over effects), in a pseudo-randomized order across patients. | Device | 1 tDCS Parietal, 2 tDCS Frontal, 3 Sham |
Primary outcome
Change in self-rating about anosognosia for USN
Time frame: from Baseline to 30 minutes
We will use a vertical visual scale on a monitor, where the patients should evaluate their performance after each trial of a neglect task.
Change in implicit measures of anosognosia for USN
Time frame: from Baseline to 30 minutes
Each self-rating will be time-locked with the brain activity of participants in order to record the so-called error-related potentials. Averaged evoked potentials for each domain of awareness will be computed, and a baseline correction will be applied to the epochs. The first error-related component (ERN) will be determined as the mean amplitude in the time window from 60 ms to 140 ms post-response onset; the second component of interest (Pe) will be determined as the mean amplitude in the time-window from 200 ms and 600 ms post-response onset.
1 secondary outcome
Lesion correlate of recovery of anosognosia for USN
Time frame: through study completion, an average of 1 year
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 30 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Stroke and Anosognosia, run by University of Geneva, 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 7 inclusion and 6 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-rating about anosognosia for USN (time frame: from Baseline to 30 minutes). 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 30 May 2025.