Neglect, HemispatialNCT06050408
Assessment of LF-rTMS in Patients With Visual Neglect
A study testing 1hz repetitive transcranial magnetic stimulation in people with Neglect, Hemispatial, run by Landspitali University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neglect, Hemispatial
- What is being tested?
- 1hz repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) History of epilepsy or seizure
- 2) Electrical device implants or metal objects in the body
- 2) Patients receiving end-of-life care
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Electrophysiological and Behavioral Assessment of Low Frequency rTMS in Patients With Visual Spatial Neglect: An Intervention Study
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).
Read the 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.
- Conditions
- Neglect, Hemispatial
- Being tested
- 1hz repetitive transcranial magnetic stimulation
- Keywords
- Visual neglect, rTMS, EEG, Stroke, Rehabilitation, Perceptual disorders, Symptom assessment
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1hz repetitive transcranial magnetic stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke group | Experimental | Patients receive treatment 6-12 weeks after stroke. Receives: Device: 1hz repetitive transcranial magnetic stimulation |
| Subacute stroke group | Experimental | Patients receive treatment 16-20 weeks after stroke. Receives: Device: 1hz repetitive transcranial magnetic stimulation |
| Chronic stroke group | Experimental | Patients receive treatment 52+ weeks after stroke. Receives: Device: 1hz repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Catherine Bergego Scale (CBS)
Scale measuring visual neglect symptoms during activities in daily life. The scale contains 10 items (each graded from 0-3) assessing: topographical orienting; navigation, underuse of hand/arm; difficulties with dressing and grooming; difficulties attending to auditory stimuli; collisions, and searching for, or identifying objects on the neglected side. The following total score indicates: 1-10 mild visual neglect, 11-20 moderate visual neglect and 21-30 severe visual neglect. Participants with score of >8 will be eligible for participating in the study.
Measured: 14 weeks
Secondary outcomes (9)
Simplified modified Rankin scale (smRS)
Functional outcome measure after stroke. Questionnaire contains 5 questions, where only three questions are asked per participants, depending on previous answers. The score ranges from 0 (total independence/perfect health) to 6 (death/no function). Higher score indicate more severe functional outcome.
Measured: 14 weeks
Neglect experience questionnaire (NEQ)
The nine-item NEQ questionnaire measures patients' experience of their own visual neglect symptoms. NEQ will be used to assess phenomenological aspects of visual neglect, which is often lacking in studies of visual neglect. The items reflect abnormal bodily experiences associated with visual neglect. The NEQ will be used in the following ways: As a clinical reference standard, as an index test, and to measure change over time. The questionnaire will be administered at each measurement session (six times), before and after each treatment period (T0 (baseline), T1(after 1st treatment period), T2(before 2nd treatment period), T3(after 2nd treatment period), T4(before 3rd treatment period) and T5(after 3rd treatment period)
Measured: 14 weeks
Patient reported outcome measure: PROMIS-10
The questionnaire will assess patients' feelings about, and perception of the treatment itself and its influence on their perception and quality of life. PROMIS-10 provide information about perceived domains of health including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Questions posed by the researcher within each of the 10 global health domains are scored by examine each item separately and score on a Likert-like scale to allow identification of specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health. The questionnaire will be administered once, at the end of the last treatment session. The same questionnaire will be administered for the relatives of the participants to assess if they noted any change in the participant's behavior or feelings following the treatment.
Measured: 14 weeks
Conventional visuo-graphic test: Star cancellation task (Index test)
The task measures lateral visual perception. Patients are presented with an A4 paper with a crowded picture with multiple stimuli distributed randomly. Patients are asked to circle with a pen around all the 54 small stars on an A4 paper. The stars are surrounded by distracting stimuli (52 large stars, 13 letters, and 10 short words). Performance will be evaluated by calculating the CoC (Center of Cancellation) score, a continuous measure of neglect severity. In cancellations tasks with distinct stimuli, the extra effort of searching for target stimuli surrounded by distractors has shown to increase sensitivity of detecting visual neglect. They also show great test-retest reliability and validity. A cutoff score of <44 indicates that the participants has visual neglect.
Measured: 14 weeks
Conventional visuo-graphic test: Line bisection task (Index test)
The line bisection task was designed for assessment of visual neglect and is a widely used task for investigating visual neglect. The line bisection task is often administered in conjunction with cancellation tasks, to capture both the allocentric and egocentric aspects of visual neglect. In the task, subjects are asked to mark the midpoint of 10 separated horizontal lines on a sheet of paper. The lines differ in length. The lines are distributed across the paper to avoid alignment of the midpoints. Leftward deviation is coded as negative and rightward deviation as positive. The score is then converted into a percentage score. The administration of the test takes under five minutes. Participants are categorized as having neglect when participants fail to mark a line on the left side of the sheet or have higher than 20% leftward bias.
Measured: 14 weeks
Conventional visuo-graphic test: Ota's circle task (Index test)
The task measures egocentric and allocentric visual neglect through cancellation of target stimuli surrounded by distractor stimuli, just like in the Star cancellation task. The task consists of circles dispersed over a sheet of paper. The instructions are to mark the circles with gaps (on either left or right side of the circle's boundary). However, the task provides an additional measure of egocentric vs allocentric neglect. Egocentric neglect will be measured as the number of hits/misses on either side of the midline. Allocentric neglect will be measured as the hits/misses of left vs right gapped circles overall. Compared to normative data from healthy participants, two or more errors on the task indicates that the participant has visual neglect.
Measured: 14 weeks
Conventional visuo-graphic test: Figure copying - Clock drawing (Index test)
The task is frequently used to measure representational neglect. Patients will be asked to copy a drawing of a regular clock via pencil on a sheet of paper. The performance is normal if the clock has the 12 hours present in all the right places. Two types of errors will be noted: 1) Omission/rightward displacement of any of the left sided hours; 2) omission/rightward displacement of all left sided hours. In addition, the size of the clock perimeter will be measured, since patients with VN tend to draw smaller clocks than healthy controls or non-VN right brain damaged controls.
Measured: 14 weeks
Conventional visuo-graphic test: Figure copying - Self portrait drawing (Index test)
Patients asked to draw a self portrait on a piece of paper. Similar to the figure copying task, the self-portrait will be used to measure representational neglect, however with instructions to draw a self-portrait from memory. Two types of errors will be noted: 1) Omission/rightward displacement of any of the left sided facial features; 2) omission/rightward displacement of all left sided facial features. The test measures a patient's mental image of their own body, therefore testing their "personal space" in contrast to "peripersonal space" which is tested in the figure copying task.
Measured: 14 weeks
Computerized attention task: Go/No-go task
Computerized behavioral attention task. The task measures inhibition and sustained attention. Stimuli are presented on a computer screen 60cm in front of the patients. Participants will see a serial presentation flow of stimuli at the center of the screen. Participants will be asked to respond to specific stimuli (numbers from 1 to 9, except the number 3). The probability of the number "3" being presented is lower than the rest, resulting in prepotency to respond to the stimulus. When the number "3" is presented, the participant must inhibit this prepotency. This task takes approx. 5 minutes to complete. Reaction time and hits/misses will be measured. Performance will be assessed over time to measure sustained attention deficits. The task is widely used as a measure for inhibition and sustained attention and has been used with patients with visual neglect.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neglect, HemispatialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups, same treatment provided in all groups but initiation of treatment after stroke differs ("acute", subacute and chronic phase).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Elisabeth Klinke, Landspitali University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050408
- Sponsor's protocol ID
- Experimental
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological and Behavioral Assessment of Low Frequency rTMS in Patients With Visual Spatial Neglect: An Intervention Study
- ClinicalTrials.gov ID
- NCT06050408
- Acronym / sponsor ID
- Experimental
- Conditions
- Neglect, Hemispatial
- Keywords
- Visual neglect, rTMS, EEG, Stroke, Rehabilitation, Perceptual disorders, Symptom assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups, same treatment provided in all groups but initiation of treatment after stroke differs ("acute", subacute and chronic phase).
| Arm | Type | Receives |
|---|---|---|
| Acute stroke group | Experimental | Device: 1hz repetitive transcranial magnetic stimulationPatients receive treatment 6-12 weeks after stroke. |
| Subacute stroke group | Experimental | Device: 1hz repetitive transcranial magnetic stimulationPatients receive treatment 16-20 weeks after stroke. |
| Chronic stroke group | Experimental | Device: 1hz repetitive transcranial magnetic stimulationPatients receive treatment 52+ weeks after stroke. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 1) History of epilepsy or seizure
- 2) Electrical device implants or metal objects in the body
- 2) Patients receiving end-of-life care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1hz repetitive transcranial magnetic stimulation1hz 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. | Device | Acute stroke group, Chronic stroke group, Subacute stroke group |
Primary outcome
The Catherine Bergego Scale (CBS)
Time frame: 14 weeks
Scale measuring visual neglect symptoms during activities in daily life. The scale contains 10 items (each graded from 0-3) assessing: topographical orienting; navigation, underuse of hand/arm; difficulties with dressing and grooming; difficulties attending to auditory stimuli; collisions, and searching for, or identifying objects on the neglected side. The following total score indicates: 1-10 mild visual neglect, 11-20 moderate visual neglect and 21-30 severe visual neglect. Participants with score of >8 will be eligible for participating in the study.
9 secondary outcomes
Simplified modified Rankin scale (smRS)
Time frame: 14 weeks
Neglect experience questionnaire (NEQ)
Time frame: 14 weeks
Patient reported outcome measure: PROMIS-10
Time frame: 14 weeks
Conventional visuo-graphic test: Star cancellation task (Index test)
Time frame: 14 weeks
Conventional visuo-graphic test: Line bisection task (Index test)
Time frame: 14 weeks
Conventional visuo-graphic test: Ota's circle task (Index test)
Time frame: 14 weeks
Conventional visuo-graphic test: Figure copying - Clock drawing (Index test)
Time frame: 14 weeks
Conventional visuo-graphic test: Figure copying - Self portrait drawing (Index test)
Time frame: 14 weeks
Computerized attention task: Go/No-go task
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing 1hz repetitive transcranial magnetic stimulation in people with Neglect, Hemispatial, run by Landspitali University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Elisabeth Klinke, PhD, MR (+3548950173, marianne@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Catherine Bergego Scale (CBS) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.