Hemispatial NeglectNCT07580066
Cerebellum and Neglect
A study testing Continuous theta burst stimulation in people with Hemispatial Neglect and Visual Neglect, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to learn if a non-invasive brain stimulation method called continuous theta burst stimulation (cTBS) can improve attention in adults who have hemispatial neglect after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemispatial Neglect, Visual Neglect, Stroke
- What is being tested?
- Continuous theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 May 2026to Apr 2030
- 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
- First-ever, subacute right hemispheric stroke
- Left-sided visual neglect defined by MGP > 1.333°
- Age ≥18 years
- Normal or corrected-to-normal visual acuity
- MRI compatibility (MRI-based neuronavigation for cTBS)
- Capacity to consent and ability to follow study procedures
Who cannot join
- Cerebellar lesion
- History of epilepsy
- Metallic implants in the head region
- Scalp or skin conditions that interfere with EEG electrode placement (e.g. open wounds, infections, severe psoriasis)
- Co-morbidities including: neurological, degenerative or major psychiatric disorder (other than index stroke), alcohol or drug abuse, severe liver or kidney disease, and active malignant tumor disease
- Pregnancy
- Enrolment in an ongoing clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Klinik für Neurologie und Neurorehabilitation
Lucerne, Canton of Lucerne, 6004
Luzerner Kantonsspital (LUKS), +41 41 205 11 11, neurozentrum.luzern@luks.ch
About this study
Official title: The Role of the Cerebellum in Recovery of Visual Neglect
The goal of this clinical trial is to learn if a non-invasive brain stimulation method called continuous theta burst stimulation (cTBS) can improve attention in adults who have hemispatial neglect after stroke. Hemispatial neglect is a common consequence of stroke where a person fails to notice things on one side of their environment and body after brain damage despite having intact sensory organs. Current treatments include physiotherapy, occupational therapy, and visual scanning training.
The main questions it aims to answer are:
Read more
- Does cTBS applied to the cerebellum shift spatial attention toward the neglected side, as measured by eye movements during a visual exploration task?
- Does cTBS change brain activity patterns linked to attention networks, as measured by EEG?
Researchers will compare different conditions, cerebellar cTBS, cerebral cTBS and sham cTBS to see which approach best improves visuospatial attention. Sham cTBS looks and feels identical to real stimulation but does not deliver effective magnetic pulses.
Participants, who are already admitted to the neurology and neurorehabilitation ward, will attend four study visits over approximately two weeks, each lasting about one hour. They receive active or sham cTBS at three stimulation sessions, each separated by at least 48 hours. They also have their eye movements recorded using a camera-based eye-tracking system before and after each session and have their brain activity recorded using EEG, a method that measures electrical activity through small electrodes on the scalp. Participation is voluntary. Participants may withdraw at any time without any impact on their regular medical care. The study is conducted at the Neurocenter of Luzerner Kantonsspital, Switzerland, and is funded by the Swiss National Science Foundation (SNF).
- Conditions
- Hemispatial Neglect, Visual Neglect, Stroke
- Being tested
- Continuous theta burst stimulation, Sham continuous theta burst stimulation
- Keywords
- Neglect, Stroke, cTMS, Cerebellum
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous theta burst stimulationDevice
cTBS delivered using a MagPro X100 stimulator with a round coil (MC-125, outer radius 60 mm). Protocol: 801 pulses in 267 bursts (3 pulses at 30 Hz, repeated at 6 Hz). Two trains applied with a 15-minute interval. Targets: left posterior inferior cerebellum (PIC; lobules VI-VIII) and left posterior parietal cortex (PPC), localized by MRI-based neuronavigation (BrainSight). Applied at 100% of individual resting motor threshold.
Sham continuous theta burst stimulationDevice
Sham stimulation delivered using the same MagPro X100 stimulator with a sham coil (MC-P-B70), which produces identical acoustic and tactile sensations as the active coil without delivering effective magnetic stimulation. Same protocol and positioning procedure as active cTBS.
| Study group | Role | What they receive |
|---|---|---|
| WP1: cTBS over left PIC. WP2: cTBS over left PPC and then over left PIC | Experimental | Not described Receives: Device: Continuous theta burst stimulation |
| WP1: cTBS over the left PPC. WP2: cTBS over left PIC and then over left PPC | Active comparator | Not described Receives: Device: Continuous theta burst stimulation |
| WP1: sham cTBS over left PIC. WP2: cTBS over left PPC and then sham cTBS over left PIC | Sham comparator | Not described Receives: Device: Continuous theta burst stimulation; Device: Sham continuous theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Gaze Position (MGP) during Free Visual Exploration (FVE)
MGP reflects the mean horizontal position (x-axis) of all fixations during free viewing of 24 naturalistic images. Recorded using an infrared video-based eye tracking system (EyeLink 1000 Plus; 1000 Hz). A MGP of 0 indicates centered fixation distribution; positive values indicate a rightward bias; negative values indicate a leftward shift. Fixations of 100-2000 ms are included. Assessed immediately before and after each cTBS session.
Measured: pre-intervention and immediatly after intervention
Secondary outcomes (3)
Electroencephalography (EEG)
64-channel scalp EEG recorded before and after each cTBS session (ActiChamp System, Brain Products). Two analysis approaches: (1) microstate analysis assessing global brain states and connectivity patterns; (2) frequency-specific phase synchronization between left and right hemispheres as a measure of interhemispheric connectivity. Impedance kept below 5 kΩ.
Measured: pre-intervention and immediatly after intervention
MRI-based structural brain connectivity and lesion mapping
Three neuroimaging analyses: (1) Voxel-based lesion-symptom mapping (VLSM) to examine the relationship between lesion location and magnitude of neglect improvement after cTBS; (2) Tractwise proportion analysis assessing lesioned tract proportions of four pathways of interest (cerebello-thalamo-cortical and interhemispheric callosal connections); (3) Correlational tractography using diffusion tensor imaging (DTI) to identify structural connectivity predictors of cTBS response. MRI acquired using a 3T Siemens Verio scanner with 32-channel head coil (MPRAGE T1: TR/TE = 2240/3.72 ms, voxel size 0.9×0.9×0.9 mm).
Measured: once at baseline
Additional Free Visual Exploration (FVE) variables
Secondary eye-tracking variables derived from the same FVE session as the primary outcome: number of fixations (left vs. right screen half), exploration time (left vs. right screen half), direction of first saccade, and exploration area. Recorded using the EyeLink 1000 Plus System (SR Research; 1000 Hz).
Measured: pre-intervention and immediatly after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start5 May 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemispatial NeglectStudies 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
- Crossover
- Model description
- randomized, sham-controlled, single-blinded crossover design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580066
- Sponsor's protocol ID
- 2026-00550
- Other IDs
- 3200-0-239875
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Cerebellum in Recovery of Visual Neglect
- ClinicalTrials.gov ID
- NCT07580066
- Acronym / sponsor ID
- 2026-00550
- Conditions
- Hemispatial Neglect, Visual Neglect, Stroke
- Keywords
- Neglect, Stroke, cTMS, Cerebellum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 12 May 2026 (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.
The goal of this clinical trial is to learn if a non-invasive brain stimulation method called continuous theta burst stimulation (cTBS) can improve attention in adults who have hemispatial neglect after stroke. Hemispatial neglect is a common consequence of stroke where a person fails to notice things on one side of their environment and body after brain damage despite having intact sensory organs. Current treatments include physiotherapy, occupational therapy, and visual scanning training.
The main questions it aims to answer are:
- Does cTBS applied to the cerebellum shift spatial attention toward the neglected side, as measured by eye movements during a visual exploration task?
- Does cTBS change brain activity patterns linked to attention networks, as measured by EEG?
Researchers will compare different conditions, cerebellar cTBS, cerebral cTBS and sham cTBS to see which approach best improves visuospatial attention. Sham cTBS looks and feels identical to real stimulation but does not deliver effective magnetic pulses.
Participants, who are already admitted to the neurology and neurorehabilitation ward, will attend four study visits over approximately two weeks, each lasting about one hour. They receive active or sham cTBS at three stimulation sessions, each separated by at least 48 hours. They also have their eye movements recorded using a camera-based eye-tracking system before and after each session and have their brain activity recorded using EEG, a method that measures electrical activity through small electrodes on the scalp. Participation is voluntary. Participants may withdraw at any time without any impact on their regular medical care. The study is conducted at the Neurocenter of Luzerner Kantonsspital, Switzerland, and is funded by the Swiss National Science Foundation (SNF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- randomized, sham-controlled, single-blinded crossover design
| Arm | Type | Receives |
|---|---|---|
| WP1: cTBS over left PIC. WP2: cTBS over left PPC and then over left PIC | Experimental | Device: Continuous theta burst stimulation |
| WP1: cTBS over the left PPC. WP2: cTBS over left PIC and then over left PPC | Active comparator | Device: Continuous theta burst stimulation |
| WP1: sham cTBS over left PIC. WP2: cTBS over left PPC and then sham cTBS over left PIC | Sham comparator | Device: Continuous theta burst stimulation, Device: Sham continuous theta burst stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First-ever, subacute right hemispheric stroke
- Left-sided visual neglect defined by MGP > 1.333°
- Age ≥18 years
- Normal or corrected-to-normal visual acuity
- MRI compatibility (MRI-based neuronavigation for cTBS)
Key exclusion criteria (7 listed)
- Cerebellar lesion
- History of epilepsy
- Metallic implants in the head region
- Scalp or skin conditions that interfere with EEG electrode placement (e.g. open wounds, infections, severe psoriasis)
- Co-morbidities including: neurological, degenerative or major psychiatric disorder (other than index stroke), alcohol or drug abuse, severe liver or kidney disease, and active malignant tumor disease
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 |
|---|---|---|
| Continuous theta burst stimulationcTBS delivered using a MagPro X100 stimulator with a round coil (MC-125, outer radius 60 mm). Protocol: 801 pulses in 267 bursts (3 pulses at 30 Hz, repeated at 6 Hz). Two trains applied with a 15-minute interval. Targets: left posterior inferior cerebellum (PIC; lobules VI-VIII) and left posterior parietal cortex (PPC), localized by MRI-based neuronavigation (BrainSight). Applied at 100% of individual resting motor threshold. | Device | WP1: cTBS over left PIC. WP2: cTBS over left PPC and then over left PIC, WP1: cTBS over the left PPC. WP2: cTBS over left PIC and then over left PPC, WP1: sham cTBS over left PIC. WP2: cTBS over left PPC and then sham cTBS over left PIC |
| Sham continuous theta burst stimulationSham stimulation delivered using the same MagPro X100 stimulator with a sham coil (MC-P-B70), which produces identical acoustic and tactile sensations as the active coil without delivering effective magnetic stimulation. Same protocol and positioning procedure as active cTBS. | Device | WP1: sham cTBS over left PIC. WP2: cTBS over left PPC and then sham cTBS over left PIC |
Primary outcome
Mean Gaze Position (MGP) during Free Visual Exploration (FVE)
Time frame: pre-intervention and immediatly after intervention
MGP reflects the mean horizontal position (x-axis) of all fixations during free viewing of 24 naturalistic images. Recorded using an infrared video-based eye tracking system (EyeLink 1000 Plus; 1000 Hz). A MGP of 0 indicates centered fixation distribution; positive values indicate a rightward bias; negative values indicate a leftward shift. Fixations of 100-2000 ms are included. Assessed immediately before and after each cTBS session.
3 secondary outcomes
Electroencephalography (EEG)
Time frame: pre-intervention and immediatly after intervention
MRI-based structural brain connectivity and lesion mapping
Time frame: once at baseline
Additional Free Visual Exploration (FVE) variables
Time frame: pre-intervention and immediatly after 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 12 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hemispatial Neglect
Recruiting
Implementation of IVS3 for Upper Limb Motor Recovery
Neglect, Hemispatial, Stroke, Cardiovascular
Not yet recruitingObservational study
Motor Imaging, Neglect, and Upper Extremity Function in Stroke
Stroke, Neglect, Hemispatial
Recruiting
Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
Stroke, Neglect, Hemispatial
Enrolling by invitation
Effectiveness of an Interactive Screen in the Rehabilitation of Neglect in Adults With Subacute Stroke: A Randomized Controlled Trial in Argentina.
Stroke, Neglect, Hemispatial
Recruiting
The Effectiveness of Transcranial Magnetic Stimulation and Mirror Therapy in Hemispatial Neglect
Hemispatial Neglect
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous theta burst stimulation in people with Hemispatial Neglect and Visual Neglect, run by Luzerner Kantonsspital at 1 site 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 6 inclusion and 7 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Thomas Nyffeler, Prof. Dr. med. (+41 41 205 56 86, thomas.nyffeler@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Gaze Position (MGP) during Free Visual Exploration (FVE) (time frame: pre-intervention and immediatly after intervention). 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 12 May 2026.