ClinicalTrials.gg
Not yet recruitingNCT07580066Updated May 12, 2026

Cerebellum and Neglect

An interventional study of Continuous theta burst stimulation and Sham continuous theta burst stimulation in Hemispatial Neglect, Visual Neglect and Stroke, sponsored by Luzerner Kantonsspital. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Luzerner Kantonsspital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Hemispatial Neglect
  • Visual Neglect
  • Stroke

Keywords

  • Neglect
  • Stroke
  • cTMS
  • Cerebellum
03

In context

Perceptual Disorders

66 studies on the registry are indexed under Perceptual Disorders; 21 are open to participants now.

This study's planned enrollment of 60 is above the median of 27 across 52 interventional studies indexed under Perceptual Disorders.

Browse Perceptual Disorders studies →

Lead sponsor

Luzerner Kantonsspital is the lead sponsor of 62 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    WP1: cTBS over left PIC. WP2: cTBS over left PPC and then over left PIC

    Device: Continuous theta burst stimulation

  • Active comparator
    WP1: cTBS over the left PPC. WP2: cTBS over left PIC and then over left PPC

    Device: Continuous theta burst stimulation

  • Sham comparator
    WP1: sham cTBS over left PIC. WP2: cTBS over left PPC and then sham cTBS over left PIC

    Device: Continuous theta burst stimulation · Device: Sham continuous theta burst stimulation

Interventions

  • DeviceContinuous theta burst stimulation

    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.

  • DeviceSham continuous theta burst stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre-intervention and immediatly after intervention

Secondary outcomes

  1. 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.

    Time frame: pre-intervention and immediatly after intervention

  2. 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).

    Time frame: once at baseline

  3. 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).

    Time frame: pre-intervention and immediatly after intervention

07

Study locations

1 site
  • Klinik für Neurologie und Neurorehabilitation
    Lucerne, Canton of Lucerne 6004, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for Apr 2030, 47 months later.

Of 27 interventional studies with no phase under Perceptual Disorders, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 134. This study's planned 47 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2026
First posted
May 12, 2026
StartEst.
May 5, 2026
Primary completionEst.
Apr 2030
CompletionEst.
Apr 2030
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07580066
Lead sponsor
Luzerner Kantonsspital
Responsible party
Sponsor
First posted
May 12, 2026
Start date
May 5, 2026 (estimated)
Primary completion
Apr 2030 (estimated)
Completion
Apr 2030 (estimated)
Last update
May 12, 2026

Study contacts

Thomas Nyffeler, Prof. Dr. med.
Contact
thomas.nyffeler@luks.ch
+41 41 205 56 86

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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