Stroke Clinical Trial
Official title:
Visual Restoration of Losses Caused by Cortical Damage: a New Protocol to Promote Fast Recovery
This is a randomized, pilot interventional study in participants with visual field deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of one half of the visual field. The goal of this project is to elaborate and refine a rehabilitation protocol for VFD participants. It is hypothesized that visual restoration training using moving stimuli coupled with noninvasive current stimulation on the visual cortex will promote and speed up recovery of visual abilities within the blind field in VFD participants. Moreover, it is expected that visual recovery positively correlates with reduction of the blind field, as measured with traditional visual perimetry: the Humphrey visual field test. Finally, although results will vary among participants depending on the extension and severity of the cortical lesion, it is expected that a bigger increase in neural response to moving stimuli in the blind visual field in cortical motion area, for those participants who will show the largest behavioral improvement after training. The overarching goals for the study are as follows: Group 1 will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic and subacute VFD stroke participant, and (ii) longitudinal testing up to 6 months post-treatment. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | October 2025 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 18 years of age or older, - Presence of some intact visual cortical areas (other than primary visual cortex) in the damaged brain hemisphere. This assessment will be made from MRI or CT scans of the subject's head, which will be obtained via standard release from their neurologist. - First ever ischemic stroke with damage to primary visual cortex, and rendered blind over a portion of their visual field. - Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry. - Willing and able to participate in the study protocol and to comply with study procedures Exclusion Criteria: - No evidence of damage to the primary visual cortex - Radiologic evidence that the stroke was hemorrhagic or non-vascular in nature - Visual cortex damage a result of a subsequent stroke (not primary) - Total cortical blindness, covering both left and right visual fields - Unable to fixate visual targets precisely or unable to perform the visual training exercises as directed. - Complete loss of reading abilities - Current or prior history of any neurological disorder other than stroke, such as epilepsy, a progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions other than the qualifying stroke lesion - Current history of poorly controlled migraines including chronic medication for migraine prevention - History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG or immediate (1st degree relative) family history of epilepsy; with the exception of a single seizure of benign etiology (e.g. febrile seizure) in the judgment of the investigator - History of fainting spells of unknown or undetermined etiology that might constitute seizures - Past or current history of major depression, bipolar disorder or psychotic disorders, or any other major psychiatric condition - Participants who are suffering from one-sided attentional neglect as determined by standard neuropsychological tests: figure cancellation and line bisection tasks. - Contraindication for receiving tRNS - Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.) - Any complex, uncontrolled/unstable or terminal medical illness - Substance abuse or dependence within the past six months. - Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination of CNS (central nervous system) active drugs. - All female participants that are pre-menopausal will be required to have a pregnancy test; any participant who is pregnant or breastfeeding will not be enrolled in the study. - Subjects who, in the investigator's opinion, might not be suitable for the study - A hair style or head dress that prevents electrode contact with the scalp or would interfere with the stimulation (for example: thick braids, hair weave, afro, wig) |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19. — View Citation
Antal A, Boros K, Poreisz C, Chaieb L, Terney D, Paulus W. Comparatively weak after-effects of transcranial alternating current stimulation (tACS) on cortical excitability in humans. Brain Stimul. 2008 Apr;1(2):97-105. doi: 10.1016/j.brs.2007.10.001. Epub 2007 Dec 3. — View Citation
Brignani D, Ruzzoli M, Mauri P, Miniussi C. Is transcranial alternating current stimulation effective in modulating brain oscillations? PLoS One. 2013;8(2):e56589. doi: 10.1371/journal.pone.0056589. Epub 2013 Feb 14. — View Citation
Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15. — View Citation
Cavanaugh MR, Zhang R, Melnick MD, Das A, Roberts M, Tadin D, Carrasco M, Huxlin KR. Visual recovery in cortical blindness is limited by high internal noise. J Vis. 2015;15(10):9. doi: 10.1167/15.10.9. — View Citation
Clark VP, Maisog JM, Haxby JV. fMRI study of face perception and memory using random stimulus sequences. J Neurophysiol. 1998 Jun;79(6):3257-65. doi: 10.1152/jn.1998.79.6.3257. — View Citation
Das A, Demagistris M, Huxlin KR. Different properties of visual relearning after damage to early versus higher-level visual cortical areas. J Neurosci. 2012 Apr 18;32(16):5414-25. doi: 10.1523/JNEUROSCI.0316-12.2012. — View Citation
Das A, Tadin D, Huxlin KR. Beyond blindsight: properties of visual relearning in cortically blind fields. J Neurosci. 2014 Aug 27;34(35):11652-64. doi: 10.1523/JNEUROSCI.1076-14.2014. — View Citation
Dombovy ML, Sandok BA, Basford JR. Rehabilitation for stroke: a review. Stroke. 1986 May-Jun;17(3):363-9. doi: 10.1161/01.str.17.3.363. — View Citation
Feurra M, Pasqualetti P, Bianco G, Santarnecchi E, Rossi A, Rossi S. State-dependent effects of transcranial oscillatory currents on the motor system: what you think matters. J Neurosci. 2013 Oct 30;33(44):17483-9. doi: 10.1523/JNEUROSCI.1414-13.2013. — View Citation
Gilhotra JS, Mitchell P, Healey PR, Cumming RG, Currie J. Homonymous visual field defects and stroke in an older population. Stroke. 2002 Oct;33(10):2417-20. doi: 10.1161/01.str.0000037647.10414.d2. — View Citation
Herpich F, Melnick MD, Agosta S, Huxlin KR, Tadin D, Battelli L. Boosting Learning Efficacy with Noninvasive Brain Stimulation in Intact and Brain-Damaged Humans. J Neurosci. 2019 Jul 10;39(28):5551-5561. doi: 10.1523/JNEUROSCI.3248-18.2019. Epub 2019 May 27. — View Citation
Huxlin KR, Martin T, Kelly K, Riley M, Friedman DI, Burgin WS, Hayhoe M. Perceptual relearning of complex visual motion after V1 damage in humans. J Neurosci. 2009 Apr 1;29(13):3981-91. doi: 10.1523/JNEUROSCI.4882-08.2009. — View Citation
Huxlin KR, Williams JM, Price T. A neurochemical signature of visual recovery after extrastriate cortical damage in the adult cat. J Comp Neurol. 2008 May 1;508(1):45-61. doi: 10.1002/cne.21658. — View Citation
Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9. — View Citation
Jones SA, Shinton RA. Improving outcome in stroke patients with visual problems. Age Ageing. 2006 Nov;35(6):560-5. doi: 10.1093/ageing/afl074. Epub 2006 Jul 4. — View Citation
Jongbloed L. Prediction of function after stroke: a critical review. Stroke. 1986 Jul-Aug;17(4):765-76. doi: 10.1161/01.str.17.4.765. — View Citation
Kavcic V, Triplett RL, Das A, Martin T, Huxlin KR. Role of inter-hemispheric transfer in generating visual evoked potentials in V1-damaged brain hemispheres. Neuropsychologia. 2015 Feb;68:82-93. doi: 10.1016/j.neuropsychologia.2015.01.003. Epub 2015 Jan 7. — View Citation
Larsson J, Heeger DJ. Two retinotopic visual areas in human lateral occipital cortex. J Neurosci. 2006 Dec 20;26(51):13128-42. doi: 10.1523/JNEUROSCI.1657-06.2006. — View Citation
Martin T, Das A, Huxlin KR. Visual cortical activity reflects faster accumulation of information from cortically blind fields. Brain. 2012 Nov;135(Pt 11):3440-52. doi: 10.1093/brain/aws272. — View Citation
Martin T, Huxlin KR, Kavcic V. Motion-onset visual evoked potentials predict performance during a global direction discrimination task. Neuropsychologia. 2010 Oct;48(12):3563-72. doi: 10.1016/j.neuropsychologia.2010.08.005. Epub 2010 Aug 14. — View Citation
Melnick MD, Tadin D, Huxlin KR. Relearning to See in Cortical Blindness. Neuroscientist. 2016 Apr;22(2):199-212. doi: 10.1177/1073858415621035. Epub 2015 Dec 10. Erratum In: Neuroscientist. 2016 Apr;22(2):213. — View Citation
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1. — View Citation
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available. — View Citation
Nitsche MA, Paulus W. Transcranial direct current stimulation--update 2011. Restor Neurol Neurosci. 2011;29(6):463-92. doi: 10.3233/RNN-2011-0618. — View Citation
Pollock A, Hazelton C, Rowe FJ, Jonuscheit S, Kernohan A, Angilley J, Henderson CA, Langhorne P, Campbell P. Interventions for visual field defects in people with stroke. Cochrane Database Syst Rev. 2019 May 23;5(5):CD008388. doi: 10.1002/14651858.CD008388.pub3. — View Citation
Raphael BA, Galetta KM, Jacobs DA, Markowitz CE, Liu GT, Nano-Schiavi ML, Galetta SL, Maguire MG, Mangione CM, Globe DR, Balcer LJ. Validation and test characteristics of a 10-item neuro-ophthalmic supplement to the NEI-VFQ-25. Am J Ophthalmol. 2006 Dec;142(6):1026-35. doi: 10.1016/j.ajo.2006.06.060. Epub 2006 Oct 13. — View Citation
Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. — View Citation
Saionz EL, Tadin D, Melnick MD, Huxlin KR. Functional preservation and enhanced capacity for visual restoration in subacute occipital stroke. Brain. 2020 Jun 1;143(6):1857-1872. doi: 10.1093/brain/awaa128. — View Citation
Santarnecchi E, Polizzotto NR, Godone M, Giovannelli F, Feurra M, Matzen L, Rossi A, Rossi S. Frequency-dependent enhancement of fluid intelligence induced by transcranial oscillatory potentials. Curr Biol. 2013 Aug 5;23(15):1449-53. doi: 10.1016/j.cub.2013.06.022. Epub 2013 Jul 25. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Motion Discrimination Change | Change in the motion discrimination computer task after training within the blind visual field | After 10 days training/stimulation and after 6 months training/stimulation | |
Secondary | Quality of Life Change | Change as assessed by the National Eye Institute 25 Item Visual Function Questionnaire (NEI-VFQ 25). The NEI-VFQ is a vision based questionnaire which evaluates quality of life with respect to vision in everyday life. The NEI-VFQ has multiple sub-scales for different areas of life, such as Near-Vision, General Health, or Ocular Pain. Each scale is scored from 0 to 100 with 100 representing the best possible score (perfect health or ability) | After 10 days training/stimulation and after 6 months training/stimulation | |
Secondary | Visual Field Change | Change of the blind area in the visual fields as measured by Humphrey perimetry. | After 10 days training/stimulation and after 6 months training/stimulation |
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