Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery

Stroke Clinical Trial

— R4V  

Official title:

Individualized Brain Stimulation to Improve Functional Rehabilitation in Two Models of Sensorimotor Disorders: Stroke and Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220449
• Other study ID #: 2017-01761
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 2023

Study information

• Verified date: January 2022
• Source: Ecole Polytechnique Fédérale de Lausanne
• Contact: Estelle Raffin, PhD
• Phone: 0216955185
• Email: estelle.raffin[@]epfl.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project assesses the effect of bifocal cross-frequency transcranial alternating current stimulation (tACS) combined with visual training to improve visual recovery and orchestrated oscillatory activity in stroke patients suffering from visual field defects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. the patient can consent for themselves;

2. age 18+ years old;

3. at least 7 days since diagnosis "stroke".

4. Patients should demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field

Exclusion Criteria:

1. Diminished capacity to consent;

2. Pregnancy

3. Known or suspected non-compliance, drug or alcohol abuse

4. Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,

5. Non-compliance to the instructions of the experimenter or an inappropriate behavior hindering the normal progress of the experiment.

6. Previous enrolment into the current study

7. Exclusion criteria of MRI, tACS, TMS

8. Use of psychoactive medication

Related Conditions & MeSH terms

• Parkinson Disease
• Stroke
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Other:
• Cross-frequency dual-site tACS
Dual site transcranial alternating current stimulation over the primary visual cortex (V1) and the mediotemporal cortex (MT/V5) using two different stimulation frequencies (Alpha and Gamma)

Locations

Country	Name	City	State
Switzerland	Campus Biotech, EPFL	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Ecole Polytechnique Fédérale de Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in visual field functions	Comparison of the systematic measurement of the visual field using Humphrey perimetry	Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Secondary	Changes in motion discrimination and integration performances	Comparison of the motion coherence threshold extracted from a two forced-choice direction discrimination task	Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Secondary	Changes in inter-areal cross-frequency interaction	Comparison of the inter-areal Alpha-Gamma coupling using electroencephalography recordings	Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Secondary	Changes in visual tracts integrity	Comparison of the diffusion weigted imaging-based tractography of the main visual tracts	Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Secondary	Changes in functional connectivity within the broad visual network	Functional MRI based connectivity analyses using DCM or graph theory will perfomed	Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)