Repetitive Transcranial Magnetic Stimulation for Post-Stroke Visual Field Defects

NCT04021160 | Completed

• 1 other identifier: 1801
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Visual field defects (VFD) usually do not show improvement beyond 12 weeks from onset. Plasticity occurs in areas of residual vision (ARV) at the visual field which are the functional counterpart of partially damaged brain regions at the areas around brain lesion. Few treatment options are currently available for post-stroke VFD. In this pilot study, the effect of repetitive transcranial magnetic stimulation (rTMS) applied to these areas on VFD in patients with cortical infarction will be studied. Patients will be divided into two groups; an active group which will receive active stimulation and a sham group which will receive placebo stimulation through a sham coil.

Conditions

Visual Fields Hemianopsia; Stroke, Ischemic; Stroke Hemorrhagic

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Mean Deviation (MD) of Automated Perimetry

  Change in mean deviation (MD) from baseline will be assessed using automated perimetry's full threshold 30-2 visual field test.

  6 weeks

Secondary Outcomes (2)

• Change in Visual Field Index (VFI) of Automated Perimetry

  6 weeks

• National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)

  6 weeks

Study Arms (2)

Active Group

ACTIVE COMPARATOR

A total of 16, every other day sessions of rTMS at 10 Hz frequency will be applied to 4 locations along the perilesional area (see target selection). Intensity will be 100% of motor threshold, 25 trains - 40 pulses per train with 20 seconds intertrain interval and a total of 1000 pulses per session. The coil handle will be directed downwards at 45º of the sagittal plain to ensure that the induced electric field be perpendicular to the underlying gyrus.

Device: High frequency repetitive transcranial magnetic stimulation (rTMS)

Sham Group

SHAM COMPARATOR

Sham group will receive the same sessions as above with the exact same parameters yet a sham coil identical in shape and size to the active coil will be used instead. The sham coil produces sounds and sensations very similar to the active one.

Device: Sham stimulation

Interventions

High frequency repetitive transcranial magnetic stimulation (rTMS) DEVICE

10hz, 20 seconds intertrain interval, 40 pulses per train with a total of 1000 pulse per session given at 100% of motor threshold. A total of 16 sessions will be given to each patient.

Active Group

Sham stimulation DEVICE

A sham coil will be used that is shielded so that it produces sounds and sensations similar to the active coil but does not produce therapeutic effects. 10hz, 20 seconds intertrain interval, 40 pulses per train with a total of 1000 pulse per session given at 100% of motor threshold. A total of 16 sessions will be given to each patient.

Sham Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a brain imaging showing vascular lesion involving visual cortical area
• Duration of at least 3 months.

You may not qualify if:

• Visual field defects of ophthalmologic origin
• Causes of severe visual impairment other than visual field defects
• Drug abuse
• Past history or family history of epilepsy
• Skull bone defects
• Implanted metallic devices

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Neuromodulation Research Lab, Neurology Department, Ain Shams University Hospital

Cairo, 11591, Egypt

Location

Related Publications (10)

• Sabel BA, Henrich-Noack P, Fedorov A, Gall C. Vision restoration after brain and retina damage: the "residual vision activation theory". Prog Brain Res. 2011;192:199-262. doi: 10.1016/B978-0-444-53355-5.00013-0.

  PMID: 21763527 BACKGROUND

• Rossini PM, Barker AT, Berardelli A, Caramia MD, Caruso G, Cracco RQ, Dimitrijevic MR, Hallett M, Katayama Y, Lucking CH, et al. Non-invasive electrical and magnetic stimulation of the brain, spinal cord and roots: basic principles and procedures for routine clinical application. Report of an IFCN committee. Electroencephalogr Clin Neurophysiol. 1994 Aug;91(2):79-92. doi: 10.1016/0013-4694(94)90029-9. No abstract available.

  PMID: 7519144 BACKGROUND

• Pambakian AL, Kennard C. Can visual function be restored in patients with homonymous hemianopia? Br J Ophthalmol. 1997 Apr;81(4):324-8. doi: 10.1136/bjo.81.4.324. No abstract available.

  PMID: 9215064 BACKGROUND

• Rowe F, Brand D, Jackson CA, Price A, Walker L, Harrison S, Eccleston C, Scott C, Akerman N, Dodridge C, Howard C, Shipman T, Sperring U, MacDiarmid S, Freeman C. Visual impairment following stroke: do stroke patients require vision assessment? Age Ageing. 2009 Mar;38(2):188-93. doi: 10.1093/ageing/afn230. Epub 2008 Nov 21.

  PMID: 19029069 BACKGROUND

• Townend BS, Sturm JW, Petsoglou C, O'Leary B, Whyte S, Crimmins D. Perimetric homonymous visual field loss post-stroke. J Clin Neurosci. 2007 Aug;14(8):754-6. doi: 10.1016/j.jocn.2006.02.022. Epub 2007 Jan 30.

  PMID: 17270447 BACKGROUND

• Barker WH, Mullooly JP. Stroke in a defined elderly population, 1967-1985. A less lethal and disabling but no less common disease. Stroke. 1997 Feb;28(2):284-90. doi: 10.1161/01.str.28.2.284.

  PMID: 9040676 BACKGROUND

• Ali M, Hazelton C, Lyden P, Pollock A, Brady M; VISTA Collaboration. Recovery from poststroke visual impairment: evidence from a clinical trials resource. Neurorehabil Neural Repair. 2013 Feb;27(2):133-41. doi: 10.1177/1545968312454683. Epub 2012 Sep 6.

  PMID: 22961263 BACKGROUND

• Janssen AM, Oostendorp TF, Stegeman DF. The coil orientation dependency of the electric field induced by TMS for M1 and other brain areas. J Neuroeng Rehabil. 2015 May 17;12:47. doi: 10.1186/s12984-015-0036-2.

  PMID: 25981522 BACKGROUND

• Perez C, Chokron S. Rehabilitation of homonymous hemianopia: insight into blindsight. Front Integr Neurosci. 2014 Oct 22;8:82. doi: 10.3389/fnint.2014.00082. eCollection 2014.

  PMID: 25374515 BACKGROUND

• Urbanski M, Coubard OA, Bourlon C. Visualizing the blind brain: brain imaging of visual field defects from early recovery to rehabilitation techniques. Front Integr Neurosci. 2014 Sep 30;8:74. doi: 10.3389/fnint.2014.00074. eCollection 2014.

  PMID: 25324739 BACKGROUND

MeSH Terms

Conditions

Hemianopsia; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: July 16, 2019
• Study Start: June 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: June 5, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)