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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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.

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 groups in NCT04845529
Study groupRoleWhat they receive
1 tDCS ParietalExperimentalAnodal tDCS applied to the right inferior parietal cortex
Receives: Device: transcranial direct current stimulation (tDCS)
2 tDCS FrontalExperimentalAnodal tDCS applied to the medial frontal cortex
Receives: Device: transcranial direct current stimulation (tDCS)
3 ShamSham comparatorSham 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.

  1. 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

  2. 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)
  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.

  1. First posted15 Apr 2021
  2. Study startDec 2026 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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)
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

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.

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