Clinical trial NCT06050408: Assessment of LF-rTMS in Patients With Visual Neglect
Official title: Electrophysiological and Behavioral Assessment of Low Frequency rTMS in Patients With Visual Spatial Neglect: An Intervention Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neglect, Hemispatial
Keywords: Visual neglect
rTMS
EEG
Stroke
Rehabilitation
Perceptual disorders
Symptom assessment
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups, same treatment provided in all groups but initiation of treatment after stroke differs ("acute", subacute and chronic phase).
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Catherine Bergego Scale (CBS)
timeFrame: 14 weeks
Secondary outcomes:
measure: Simplified modified Rankin scale (smRS)
timeFrame: 14 weeks
measure: Neglect experience questionnaire (NEQ)
timeFrame: 14 weeks
measure: Patient reported outcome measure: PROMIS-10
timeFrame: 14 weeks
measure: Conventional visuo-graphic test: Star cancellation task (Index test)
timeFrame: 14 weeks
measure: Conventional visuo-graphic test: Line bisection task (Index test)
timeFrame: 14 weeks
measure: Conventional visuo-graphic test: Ota's circle task (Index test)
timeFrame: 14 weeks
measure: Conventional visuo-graphic test: Figure copying - Clock drawing (Index test)
timeFrame: 14 weeks
measure: Conventional visuo-graphic test: Figure copying - Self portrait drawing (Index test)
timeFrame: 14 weeks
measure: Computerized attention task: Go/No-go task
timeFrame: 14 weeks
Other outcomes:
measure: National Institute of Health Stroke Scale (NIHSS) picture description to screen for SN (Index test)
timeFrame: Within 5 days from stroke.
Locations:
Study officials:
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