Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Visual Field Deficits With Noninvasive Brain Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085210
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Lorella Battelli, Beth Israel Deaconess Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Visual Field Defect, Peripheral Stroke Visual Impairment Hemianopsia Device: transcranial random noise stimulation (tRNS) Behavioral: Computer Based Visual Training Device: Sham stimulation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

Randomized, pilot interventional study in participants with visual field deficit (VFD). Group 1 aims to examine the effects of two weeks (10 days) of visual training with tRNS vs visual training with sham tRNS. Group 2 will examine two weeks (10 days) of tRNS vs 2 weeks of sham tRNS (no visual training). Baseline assessments consist of visual field perimetry, neurological exam, EEG, MRI and quality of life assessment. Participants will be randomly assigned within each group to one of two interventions:

Study Group 1:

Two weeks of daily sham tRNS sessions with training Two weeks of daily tRNS sessions with training

Study Group 2:

Two weeks of daily sham tRNS sessions (no training) Two weeks of daily tRNS sessions (no training)

Masking: Double (Participant, Investigator)
Masking Description:

Randomization for sham vs actual stimulation will be conducted by a predetermined member of the research team, ensuring that participants, care providers, investigators and outcome assessors all remain blinded to the intervention at the time of each assessment. Stimulation and EEG templates for real and Sham tRNS will not differ. The "double blind mode" of the stimulation software will be used for blinding. When the function is active, the operator can only monitor electrodes' impedance values before the stimulation begins, while no information is displayed during stimulation. The same number of stimulating electrodes will be used for real and Sham tRNS.

Given this is a pilot study and that both groups receive randomization over the type of stimulation we do not anticipate that randomization for enrolling subjects into group 1 or 2 is necessary.

Primary Purpose: Treatment
Official Title: Visual Restoration of Losses Caused by Cortical Damage: a New Protocol to Promote Fast Recovery
Estimated Study Start Date : December 15, 2021
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Arm Intervention/treatment
Experimental: Visual Training with Noninvasive Brain Stimulation
10 daily (Monday-Friday) 20-30 minute sessions of tRNS with visual training on the computer
Device: transcranial random noise stimulation (tRNS)
noninvasive current stimulation for 20 - 30 minutes stimulation on visual cortex (electrodes on surface of scalp, positioned O1 / O2 on EEG cap). 1mA max amplitude noise stimulation, frequencies from 100 Hz - 640 Hz.

Behavioral: Computer Based Visual Training
Dynamic visual stimuli are presented on specific locations of the visual field. Participant holds fixation on center of screen during presentation of visual stimuli. Participants will be presented with multiple trials of a motion discrimination task. Training will be performed for 2 weeks (10 consecutive weekdays), 30 minutes each day.

Experimental: Visual Training with Sham Stimulation
10 daily (Monday-Friday) 20-30 minute sessions of sham stimulation with visual training on the computer
Behavioral: Computer Based Visual Training
Dynamic visual stimuli are presented on specific locations of the visual field. Participant holds fixation on center of screen during presentation of visual stimuli. Participants will be presented with multiple trials of a motion discrimination task. Training will be performed for 2 weeks (10 consecutive weekdays), 30 minutes each day.

Device: Sham stimulation
20-30 minutes sham stimulation on visual cortex. Participants receive identical setup to real stimulation. The device provides a short ramp on period to simulate the feeling of real stimulation at the start but no current is delivered otherwise.

Experimental: Noninvasive Brain Stimulation without visual training
10 daily (Monday-Friday) 20-30 minute sessions of tRNS alone
Device: transcranial random noise stimulation (tRNS)
noninvasive current stimulation for 20 - 30 minutes stimulation on visual cortex (electrodes on surface of scalp, positioned O1 / O2 on EEG cap). 1mA max amplitude noise stimulation, frequencies from 100 Hz - 640 Hz.

Sham Comparator: Sham Stimulation without visual training
Placebo control. Simulation of tRNS without receiving any actual stimulation
Device: Sham stimulation
20-30 minutes sham stimulation on visual cortex. Participants receive identical setup to real stimulation. The device provides a short ramp on period to simulate the feeling of real stimulation at the start but no current is delivered otherwise.




Primary Outcome Measures :
  1. Visual Motion Discrimination Change [ Time Frame: After 10 days training/stimulation and after 6 months training/stimulation ]
    Change in the motion discrimination computer task after training within the blind visual field


Secondary Outcome Measures :
  1. Quality of Life Change [ Time Frame: After 10 days training/stimulation and after 6 months training/stimulation ]
    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)

  2. Visual Field Change [ Time Frame: After 10 days training/stimulation and after 6 months training/stimulation ]
    Change of the blind area in the visual fields as measured by Humphrey perimetry.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085210


Contacts
Layout table for location contacts
Contact: Lorella Battelli, PhD 617-667-0209 ext 70209 lbattell@bidmc.harvard.edu
Contact: Thomas Pandolfi, BS 617-667-0209 ext 70209 tpandolf@bidmc.harvard.edu

Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Lorella Battelli, PhD Beth Israel Deaconess Medical Center
Publications:

Layout table for additonal information
Responsible Party: Lorella Battelli, Assistant Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05085210    
Other Study ID Numbers: 2021P000804
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lorella Battelli, Beth Israel Deaconess Medical Center:
Visual Field defects
Occipital Stroke
Ischemic Stroke
visual cortex
noninvasive brain stimulation
transcranial direct current stimulation
visual training
visual recovery
Additional relevant MeSH terms:
Layout table for MeSH terms
Vision Disorders
Vision, Low
Hemianopsia
Nervous System Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Blindness