Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy
|ClinicalTrials.gov Identifier: NCT02866240|
Recruitment Status : Unknown
Verified July 2017 by Neuroelectrics Corporation.
Recruitment status was: Recruiting
First Posted : August 15, 2016
Last Update Posted : July 13, 2017
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. Patients will be recruited from the epilepsy clinics of Boston Children's Hospital (BCH) and Beth Israel Deaconess Medical Center (BIDMC), the home institutions of the principal investigators. 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/4-week period) as compared to baseline. Secondary outcome measures include change in interictal discharge burden, change in cortical excitability, and quality of life measures.
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 4 and 8 weeks after the completion of the tDCS visits
|Condition or disease||Intervention/treatment||Phase|
|Refractory Epilepsy||Device: Cathodal Transcranial Direct Current Stimulation (tDCS).||Not Applicable|
Noninvasive neurostimulation techniques include Transcranial magnetic stimulation (TMS) and Cathodal Transcranial Direct Current Stimulation (tDCS). Of these, tDCS is uniquely suited to mass distribution and treatment, even at home, as it is lightweight, portable, inexpensive and has a favorable safety profile. In tDCS, a low intensity (1-2 mA) unidirectional electrical current is applied to the scalp to influence underlying cortical excitability. Some small preliminary studies suggest that cathodal tDCS may suppress epileptic seizures [1,2]. However, a well-powered randomized-controlled trial demonstrating convincing proof of efficacy has not been conducted. This study is intended to test whether tDCS reduces seizures in patients with intractable focal neocortical epilepsy. The hypothesis is that repeated daily sessions of cathodal tDCS will lead to a clinically significant decrease in seizures in this population. Successful completion of this pilot study will be an essential first step toward a larger placebo-controlled trial with the goal of establishing cathodal tDCS as a novel, non-invasive and inexpensive treatment for drug-resistant seizures, and will provide the critical data needed for an application to obtain FDA approval for the use of tDCS in the treatment of drug-resistant epilepsy.
tDCS is a painless method for focal brain stimulation. tDCS is based on decades-old observations that neuronal firing is modulated by low amplitude electrical direct current (DC). Specifically, when applied to the cerebral cortex, cathodal DC inhibits neuronal firing [3,4]. The mechanisms by which cathodal DC reduces neuronal firing likely relate to hyper‐polarization of the soma membrane which occurs when the apical dendrites neuron are oriented toward the cathode in a constant electric field . The practical application of tDCS is simple: low amplitude DC is administered via scalp electrodes such that the cerebral cortex is exposed to cathodal DC beneath one of the electrodes, and the return (anodal) electrodes can be placed anywhere else on the body, or in more complex arrangements to minimize currents at any one site. tDCS methods have also recently been adapted to rats for work with disease models showing success with seizure suppression [6,7]. Hundreds of tDCS trials have demonstrated the technique to be well tolerated and safe. Direct electrical current stimulation is presently FDA-approved for extracranial use, and FDA applications for cranial stimulation (tDCS) for management of mood disorder and chronic pain are in progress. tDCS units are also inexpensive and light-weight. The electrical supply can be derived from conventional 9-volt batteries. The scalp electrodes can be fastened in seconds. tDCS can be combined easily with other therapies, such as those that may be required for resuscitation of an acutely-injured patient. tDCS is presently under investigation as a treatment for epilepsy, where excess cortical excitability is a prominent feature of the disease process, and where neuronal inhibition may be beneficial. Thus for epilepsy, tDCS may offer a practical non-pharmacologic therapy for the large minority, approximately 35%, of patients whose seizure cannot be controlled by medication.
The tDCS stimulator used in this clinical study is the STARSTIM device (Neuroelectrics, Inc). STARSTIM is capable of recording EEG before, during and after tDCS stimulation, and will not only allow for a detailed understanding of the tDCS-induced effect on neural activity, but may eventually serve as a guidance to fine-tune the stimulation parameters and improve the tDCS protocol based on the developmental, behavioral, dynamical, and disease state through closed-loop systems.
Starstim device is remotely controlled using NIC software that stands for Neuroelectrics Instrument Controller (NIC). This application will allow physicians to configure the study protocol with all the defined parameters. The provided version of software will only enable to apply tDCS protocols to the subjects in the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Therapeutic Measures of Cathodal Transcranial Direct Current Stimulation (Tdcs) in Patients With Refractory Focal Epilepsy|
|Actual Study Start Date :||June 21, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: Single arm
Cathodal Transcranial Direct Current Stimulation (tDCS)
Device: Cathodal Transcranial Direct Current Stimulation (tDCS).
Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.
- Seizure frequency in patients with intractable focal neocortical epilepsy using cathodal tDCS. [ Time Frame: 16 weeks ]
- Improvement in quality of life (QOL) and cognition in patients with Epilepsy having [ Time Frame: 16 weeks ]
- Improvement in quality of life (QOL) in patients with Epilepsy having cathodal tDCS through NIH Toolbox® Emotion Battery. [ Time Frame: 16 weeks ]
- Frequency of interictal epileptiform discharges burden in patients with epilepsy having cathodal tDCS. [ Time Frame: 16 weeks ]
- Change in cortical excitability measures in patients with epilepsy having cathodal tDCS, and correlation with seizure outcomes . [ Time Frame: 16 weeks ]
- Improvement in cognition in patients with Epilepsy having cathodal tDCS through NIH Toolbox® Cognition Battery. [ Time Frame: 16 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866240
|Contact: Alex Rotenberg, M.D., Ph.D.||email@example.com|
|United States, Massachusetts|
|Boston Children´S Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: ALEXANDER ROTENBERG, MD, PHD 617-355-6000 firstname.lastname@example.org|
|Sub-Investigator: MOUHSIN SHAFI, MD,PHD|
|Principal Investigator:||Alex Rotenber, M.D., Ph.D.||Boston Children’s Hospital|