NCT02866240

Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy

Completed NA Last updated 11 January 2021

What this trial tests

NA trial testing Cathodal Transcranial Direct Current Stimulation (tDCS). in Refractory Epilepsy in 20 participants. Completed in 31 December 2019.

Timeline

21 September 2017

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Neuroelectrics Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	21 September 2017
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Cathodal Transcranial Direct Current Stimulation (tDCS).

Conditions studied

• Refractory Epilepsy — all drugs for Refractory Epilepsy →

Sponsor

Neuroelectrics Corporation — full company profile →

Who can join

9 and older, any sex, with Refractory Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single site, non-randomized, prospective, open-label, interventional pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure onsets originating from the lateral cortical surface of any lobe. All patients and referring physicians will be requested to maintain their current antiepileptic drugs throughout the study with changes after enrollment permitted only to maintain pre-enrollment drug levels, or if clinically necessary. The primary outcome measure will be the change in seizure frequency (seizures/week) as compared to baseline.

Patients with medically-refractory neocortical epilepsy will receive cathodal tDCS administered to the seizure focus for 10 sessions over a 2-week period with the allowance of make-up sessions in week three. Subjects will be evaluated at baseline, during the stimulation sessions, and 8 weeks after the completion of the tDCS visits

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
   Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124