Cerebellum and Neglect

NCT07580066 | Not Yet Recruiting DMC

• 2 other identifiers: 2026-005503200-0-239875
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hemispatial Neglect; Visual Neglect; Stroke

Keywords

Neglect; Stroke; cTMS; Cerebellum

Outcome Measures

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.

  pre-intervention and immediatly after intervention

Secondary Outcomes (3)

• Electroencephalography (EEG)

  pre-intervention and immediatly after intervention

• MRI-based structural brain connectivity and lesion mapping

  once at baseline

• Additional Free Visual Exploration (FVE) variables

  pre-intervention and immediatly after intervention

Study Arms (3)

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

Interventions

Continuous theta burst stimulation DEVICE

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.

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 stimulation DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Sites (1)

Klinik für Neurologie und Neurorehabilitation

Lucerne, Canton of Lucerne, 6004, Switzerland

Location

MeSH Terms

Conditions

Perceptual Disorders; Stroke

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Thomas Nyffeler, Prof. Dr. med.

CONTACT

+41 41 205 56 86; thomas.nyffeler@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, sham-controlled, single-blinded crossover design

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 12, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)