Assessment of LF-rTMS in Patients With Visual Neglect

NCT ID: NCT06050408

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Neglect, Hemispatial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 groups, same treatment provided in all groups but initiation of treatment after stroke differs ("acute", subacute and chronic phase).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acute stroke group

Patients receive treatment 6-12 weeks after stroke.

Group Type EXPERIMENTAL

1hz repetitive transcranial magnetic stimulation

Intervention Type DEVICE

1hz rTMS applied over P3 EEG 10-20 location. Total of 1200 pulses administered. Figure of eight coil used to stimulate, held tangential to the scalp.

Subacute stroke group

Patients receive treatment 16-20 weeks after stroke.

Group Type EXPERIMENTAL

1hz repetitive transcranial magnetic stimulation

Intervention Type DEVICE

1hz rTMS applied over P3 EEG 10-20 location. Total of 1200 pulses administered. Figure of eight coil used to stimulate, held tangential to the scalp.

Chronic stroke group

Patients receive treatment 52+ weeks after stroke.

Group Type EXPERIMENTAL

1hz repetitive transcranial magnetic stimulation

Intervention Type DEVICE

1hz rTMS applied over P3 EEG 10-20 location. Total of 1200 pulses administered. Figure of eight coil used to stimulate, held tangential to the scalp.

Interventions

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1hz repetitive transcranial magnetic stimulation

1hz rTMS applied over P3 EEG 10-20 location. Total of 1200 pulses administered. Figure of eight coil used to stimulate, held tangential to the scalp.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Landspitali University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Elisabeth Klinke

Professor in Nursing and academic chair in neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Marianne Elisabeth Klinke, PhD, MR

Role: CONTACT

+3548950173

Eysteinn Ívarsson, MSc

Role: CONTACT

+3546624760

Other Identifiers

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Experimental

Identifier Type: -

Identifier Source: org_study_id

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