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Cerebellum and Neglect

6 maj 2026 uppdaterad av: Luzerner Kantonsspital

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:

  • 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).

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Canton of Lucerne
      • Lucerne, Canton of Lucerne, Schweiz, 6004
        • Klinik für Neurologie und Neurorehabilitation
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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:

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: WP1: cTBS over left PIC. WP2: cTBS over left PPC and then over left PIC
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.
Aktiv komparator: WP1: cTBS over the left PPC. WP2: cTBS over left PIC and then over left PPC
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 Comparator: WP1: sham cTBS over left PIC. WP2: cTBS over left PPC and then sham cTBS over left PIC
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 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Gaze Position (MGP) during Free Visual Exploration (FVE)
Tidsram: 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.
pre-intervention and immediatly after intervention

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Electroencephalography (EEG)
Tidsram: pre-intervention and immediatly after intervention
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.
pre-intervention and immediatly after intervention
MRI-based structural brain connectivity and lesion mapping
Tidsram: once at baseline
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).
once at baseline
Additional Free Visual Exploration (FVE) variables
Tidsram: pre-intervention and immediatly after intervention
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).
pre-intervention and immediatly after intervention

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

5 maj 2026

Primärt slutförande (Beräknad)

1 april 2030

Avslutad studie (Beräknad)

1 april 2030

Studieregistreringsdatum

Först inskickad

30 april 2026

Först inskickad som uppfyllde QC-kriterierna

6 maj 2026

Första postat (Faktisk)

12 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2026-00550
  • 3200-0-239875 (Annat bidrag/finansieringsnummer: Schweizerischer Nationalfonds SNF (Swiss National Science Foundation SNSF))

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