Effects of Prism Adaption and rTMS on Brain Connectivity and Visual Representation

NCT02911129 | Completed

• 2 other identifiers: 16017016-N-0170
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Background: After a stroke, the balance between the two halves of the brain can be lost. This may cause people to lose the ability to perceive a side of space. This is called neglect. Having people wear prism glasses (called PA) can reduce neglect symptoms. Researchers want to find out more about how PA, and whether it restores the balance in the brain. Objective: To learn how prism adaption temporarily changes vision and connections in the brain. Eligibility: People ages 18 75 with brain damage of the right side of the brain from a stroke or other cause, leading to neglect. Healthy volunteers ages 18 75. Design: Participants will have 1 3 visits. Participants will be screened with a neurological exam. They may also have: Tests of thinking and vision Tests to see which eye and hand they prefer A pregnancy test All participants will: Answer questions about their personality, style of thinking, and beliefs. Do simple tasks on paper or computer Have magnetic resonance imaging. They will lie on a table that can slide in and out of a cylinder in a strong magnetic field. Participants will lie still or do computer tasks in the scanner. Participants may also have: Transcranial magnetic stimulation. A brief electrical current passes through a wire coil on the scalp. This creates a magnetic pulse that affects brain activity. Participants may be asked to tense certain muscles or perform simple actions or tasks. PA. They will sit in front of a board and point to a dot on it while they wear prism glasses that shift vision to the left or right....

Conditions

Normal Physiology; Stroke

Keywords

Chronic Stroke; Neglect; Transcranial Magnetic Stimulation; Visual and Motor Integration; Visual Fields; Natural History

Outcome Measures

Primary Outcomes (3)

• Experiment 1: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after rPA in neglect patients.

  Measurement of Change

  1 week

• Experiments 2: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after rPA or lPA or nPA.

  Measurement of change

  1 week

• Experiment 3: The primary outcome measure will be the change in the strength of the fronto-parietal resting state network (RSN) after cTBS over the PPC versus cTBS over the vertex.

  Measurement of change

  3 weeks

Secondary Outcomes (3)

• Experiment 1: The change of preferred center and size in the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA.

  1 week

• Experiments 2: The change of preferred center and sizein the different region of interest (ROI) in the parietal cortex, and the change in open loop pointing task performances after rPA or lPA, or nPA

  1 week

• Experiments 3: The change in perceptual line bisection performances after r cTBS over PPC or cTBS over the vertex.

  1 week

Study Arms (2)

Healthy Volunteer

Inclusion Criteria for Healthy Volunteers/Age-matched Controls

Patients

Patients with neglect after a right hemisphere brain lesion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary Clinical

You may qualify if:

• All participants must have had a neurological examination by a NINDS physician within the last two years, a clinical MRI within the last year, and be able to read, write and speak English.
• Experiment 2 requires 63 healthy volunteers having right dominant eye and 21 volunteers having left dominant eye. Therefore, healthy volunteers with left dominant eye will be recruited until the necessary number is reached. We estimate we will have to screen 150
• healthy volunteers. Participants for whom the study was not completed due to technical problems and who did not undergo prism adaptation or TMS will be retested and data from the incomplete session will not be analyzed.
• Experiment 1
• Age 18-75 (inclusive; we will try to match this to the stroke group)
• Montreal Cognitive Assessment score greater than or equal to 26
• Absence of neglect at time of testing (Diller test score less than or equal to 2)
• Experiments 2 and 3
• Right-handedness
• Age 18-35 (inclusive)
• Twelve or more years of education
• Are able to see a dot of size 0.2 inches at a distance of 22.5 inches without glasses or with contact lenses (only for Experiment 2)
• Experiment 1
• Age 18-75 (inclusive)
• Montreal Cognitive Assessment score greater than or equal to 26

You may not qualify if:

• Significant illness affecting the central nervous system
• History of seizure (for Experiment 3)
• Inability to give informed consent
• Concurrent use of sedating medications
• Trained to write in other than left to right direction
• Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, or ocular foreign body
• Implanted cardiac pacemaker or auto-defibrillator or pump
• Non-removable body piercing
• Claustrophobia
• Inability to lie supine for 1.5 hour
• Pregnancy
• Members of the NINDS Behavioral Neurology Unit (BNU)
• Significant illness affecting the central nervous system, other than right hemisphere lesion causing neglect in patients
• Inability to give informed consent
• Concurrent use of sedating medications

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eric M Wassermann, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 22, 2016
• Study Start: November 4, 2016
• Primary Completion: December 21, 2018
• Study Completion: February 24, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

US (1)