Refractory Epilepsy Clinical Trial
— BLUELIGHTVNSOfficial title:
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
NCT number | NCT06304389 |
Other study ID # | BLUELIGHT-VNS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | April 2026 |
Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | April 2026 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: Patients: VNS implanted since at least 3 months age >18-60 years; IQ >55 on Wechsler scale (normal status or mild cognitive impairment) healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease) Exclusion criteria: Patients: other medical implanted devices than VNS, ocular diseases Helthy participants: medical implanted devices, cerebral trauma, ocular disease |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint Luc | Woluwe-Saint-Lambert |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of blue light on VNS biomarkers | Blue light increases VNS induced electroencephalogram desynchronisation in implanted patients | 4 years | |
Primary | Effect of blue light on VNS biomarkers | Blue light increases P300 amplitude in VNS implanted patients | 4 years | |
Primary | Effect of blue light on VNS biomarkers | Blue light increases VNS (or tVNS) induced pupil dilation (in patients & healthy subjects). | 4 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02866240 -
Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy
|
N/A | |
Withdrawn |
NCT04753983 -
A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy
|
N/A | |
Completed |
NCT01899898 -
Efficacy of a Simplified Modified Atkins Diet in Children With Refractory Epilepsy
|
Phase 2/Phase 3 | |
Recruiting |
NCT05493722 -
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
|
Early Phase 1 | |
Recruiting |
NCT03062514 -
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
|
N/A | |
Recruiting |
NCT04770337 -
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
|
N/A | |
Recruiting |
NCT05232630 -
Fenfluramine for the Treatment of Different Types of Developmental and Epileptic Encephalopathies: a Pilot Trial Exploring Epileptic and Non-epileptic Outcomes
|
Phase 4 | |
Completed |
NCT04545346 -
The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy
|
N/A | |
Not yet recruiting |
NCT04542629 -
Comparative Study of Dietary and Immunological Management of Refractory Epilepsy in Children
|
Phase 4 | |
Terminated |
NCT03570489 -
Randomized Controlled Trial on Cardiovascular Exercise in Uncontrolled Epilepsy:
|
N/A | |
Completed |
NCT05031208 -
Acute and Long Term Effects of VNS on Memory in Patients With Refractory Epilepsy
|
N/A | |
Completed |
NCT01880333 -
Evaluation of the Modified Atkins Diet in Young Children With Refractory Epilepsy
|
Phase 2/Phase 3 | |
Completed |
NCT03676569 -
Intrathecal Autologous ADRC Treatment of Autoimmune Refractory Epilepsy
|
Phase 1 | |
Withdrawn |
NCT03115489 -
Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus
|
Phase 2/Phase 3 | |
Completed |
NCT02876289 -
Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
|
N/A | |
Completed |
NCT01521754 -
Product Surveillance Registry- Deep Brain Stimulation for Epilepsy
|
||
Recruiting |
NCT04684797 -
Localization of the Reward Positivity to ACC
|
N/A | |
Completed |
NCT05292183 -
Modulation of Emotion Perception in Humans Via Amygdala Stimulation
|
N/A | |
Terminated |
NCT04398667 -
European Non-interventional Study on Refractory Epilepsy With Developmental Delay
|
||
Active, not recruiting |
NCT04218812 -
Clinical Utility of Automated Electric Source Imaging in Presurgical Evaluation
|
N/A |