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NCT05085210Fut, nem toboroz

Improving Visual Field Deficits With Noninvasive Brain Stimulation

Visual Restoration of Losses Caused by Cortical Damage: a New Protocol to Promote Fast Recovery

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 6.

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Rövid összefoglaló (regiszter, angolul)

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 or an eye-tracker based visual perimetry implemented in a virtual reality (VR) headset. Finally, although results will vary among participants depending on the extent 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 1a will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual training on a Virtual Reality (VR) device in stroke cohorts, including both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
24 (tervezett)
Első benyújtás
2021. okt. 7.
Kezdés
2022. jan. 25.
Elsődleges befejezés
2026. dec.
Fő szponzor
Beth Israel Deaconess Medical Center
NCT-szám
NCT05085210

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 24
  • 2022. jan. 25. és az elsődleges befejezés (2026. dec.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

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Korábbi kezelés

  • 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.
  • Contraindication for receiving tRNS.

Más betegség

  • Visual cortex damage as a result of a subsequent stroke (not primary).
  • 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.
  • 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.
  • Medications will be reviewed by the responsible MD (Drs. Sandeep Kumar or Dan Press) 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 active drugs.
  • Additional criteria for Group 1b only: Contraindication for using VR technology, specifically an implanted medical device such as a pacemaker, implanted defibrillator, deep brain or vagal nerve stimulator. Participants with a history of seizures are already excluded per the above criteria.

Egyéb

  • No evidence of damage to the primary visual cortex.
  • 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.
  • Participants who are suffering from one-sided attentional neglect as determined by standard neuropsychological tests: figure cancellation and line bisection tasks.
  • Substance abuse or dependence within the past six months.
  • 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).

Kiket keres a vizsgálat

  • 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 or hemorrhagic stroke with damage to primary visual cortex, and rendered blind over a portion of their visual field.
    • Ischemic stroke patients will be either subacute (within 6 months of their stroke) or chronic (more than 6 months)
    • Hemorrhagic stroke patients will be chronic only (greater than 6 months)
  • Must demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field as measured by visual perimetry.
  • Imaging evidence that the stroke is primarily affecting the visual cortex.
  • Willing and able to participate in the study protocol and to comply with study procedures.

Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Beth Israel Deaconess Medical CenterBostonEgyesült ÁllamokIsmeretlen állapot

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