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Assessment of LF-rTMS in Patients With Visual Neglect

L

Landspítali – National University Hospital of Iceland

Status

Not yet enrolling

Conditions

Neglect, Hemispatial

Treatments

Device: 1hz repetitive transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06050408
Experimental

Details and patient eligibility

About

Visual neglect is a common disorder following stroke and an indicator of poor recovery compared to stroke survivors without visual neglect. The goal of this intervention study is to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in reducing visual neglect symptoms in patients following a stroke. The aim is to answer these questions: 1. Does rTMS decrease visual neglect symptoms in patients following a stroke? 2. If the treatment works, when in the rehabilitation process is it most effective to provide the treatment (6-12 weeks, 16-42 weeks or 52+ weeks after the stroke).

Full description

Visual neglect is a common disorder following stroke and an indicator of poor recovery compared to stroke survivors without visual neglect. Available treatment options are lacking, showing only partial and short lived effects. The goal of this intervention study is to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) in reducing visual neglect symptoms in patients following a stroke. The aim is to answer these questions: 1. Does rTMS decrease visual neglect symptoms in patients following a stroke? 2. If the treatment works, when in the rehabilitation process is it most effective to provide the treatment (6-12 weeks, 16-42 weeks or 52+ weeks after the stroke)? Participants will undergo 1 hz low frequency rTMS treatment period of 10 days at a time. Three treatment periods will be provided, with one month of delay time in-between periods. Repeated treatment will be provided to assess if any cumulative effects appear. Participants will be assessed with behavioral tasks, phenomenological questionnaires and electroencephalography (EEG) before and after each treatment period.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

    1. Diagnosed with visual neglect up to 10 years prior to the study.
    1. Age between 18-80 years old.
    1. CBS score of >8
    1. Informed consent provided by patient or proxy.

Exclusion criteria

    1. History of epilepsy or seizure
    1. Electrical device implants or metal objects in the body
    1. Patients receiving end-of-life care

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Acute stroke group
Experimental group
Description:
Patients receive treatment 6-12 weeks after stroke.
Treatment:
Device: 1hz repetitive transcranial magnetic stimulation
Subacute stroke group
Experimental group
Description:
Patients receive treatment 16-20 weeks after stroke.
Treatment:
Device: 1hz repetitive transcranial magnetic stimulation
Chronic stroke group
Experimental group
Description:
Patients receive treatment 52+ weeks after stroke.
Treatment:
Device: 1hz repetitive transcranial magnetic stimulation

Trial contacts and locations

0

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Central trial contact

Marianne Elisabeth Klinke, PhD, MR; Eysteinn Ívarsson, MSc

Data sourced from clinicaltrials.gov

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