NCT06050408

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

July 26, 2023

Last Update Submit

September 15, 2023

Conditions

Neglect, Hemispatial

Keywords

Visual neglectrTMSEEGStrokeRehabilitationPerceptual disordersSymptom assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

    14 weeks

Secondary Outcomes (9)

  • Simplified modified Rankin scale (smRS)

    14 weeks

  • Neglect experience questionnaire (NEQ)

    14 weeks

  • Patient reported outcome measure: PROMIS-10

    14 weeks

  • Conventional visuo-graphic test: Star cancellation task (Index test)

    14 weeks

  • Conventional visuo-graphic test: Line bisection task (Index test)

    14 weeks

  • +4 more secondary outcomes

Other Outcomes (1)

  • National Institute of Health Stroke Scale (NIHSS) picture description to screen for SN (Index test)

    Within 5 days from stroke.

Study Arms (3)

Acute stroke group

EXPERIMENTAL

Patients receive treatment 6-12 weeks after stroke.

Device: 1hz repetitive transcranial magnetic stimulation

Subacute stroke group

EXPERIMENTAL

Patients receive treatment 16-20 weeks after stroke.

Device: 1hz repetitive transcranial magnetic stimulation

Chronic stroke group

EXPERIMENTAL

Patients receive treatment 52+ weeks after stroke.

Device: 1hz repetitive transcranial magnetic stimulation

Interventions

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.

Acute stroke groupChronic stroke groupSubacute stroke group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Perceptual DisordersStroke

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Marianne Elisabeth Klinke, PhD, MR

CONTACT

+3548950173marianne@hi.is

Eysteinn Ívarsson, MSc

CONTACT

+3546624760eysteini@landspitali.is

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups, same treatment provided in all groups but initiation of treatment after stroke differs ("acute", subacute and chronic phase).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Nursing and academic chair in neurology

Study Record Dates

First Submitted

July 26, 2023

First Posted

September 22, 2023

Study Start

September 15, 2023

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share