News Release

Background

Transcranial electric stimulation(tES), in particular transcranial direct current stimulation (tDCS), has emerged as a widely distributed research tool for influencing human brain function. Its simplicity and low cost has contributed substantially to its do-it-yourself (DIY) use for brain enhancement or even treatment of diseases in lay populations. Here, we define DIY as self-application of tES without fully conforming to a verified efficacious protocol and/or using a device that has not been certified. DIY-ers are either healthy subjects looking for neuroenhancement and/or patients (most frequently chronic pain, seasonal affective and generalized anxiety disorders, bipolar or schizophrenic patients) seeking treatment. Their primary goal is self-improvement or self-treatment on a self-observational basis.

Recommendation

Necessary conditions: Given this situation, the IFCN recommends that for any use of tES in the treatment of a medical indication (at home or in the clinic) this should be done with a medical grade device or consumer device (CE mark) and under supervision of a medical provider and trained personnel. In the United States, devices having been approved for Over-The-Counter (Non-Prescription) by the governing regulatory agency may also be used by law.

Necessary and sufficient conditions: In medical applications, a necessary and sufficient condition is the use of protocols, which have demonstrated in peer-reviewed clinical trials to be both safe and efficacious. The manufacturer should have this information in the user manual, based on clinical evaluations. In non-medical applications, efficacy and safety should also be standard, including home-use. Many scientific investigations have shown both positive and negative results for circumscribed cognitive processes in special investigations. As many

‘home-applied’ protocols have not been formally tested, and many sensitive parameters have not been carefully reproduced, stimulation may switch positive into negative results.

Thus, the IFCN warns against the use of DIY devices and methods unless they have shown both efficacy and safety.

 


Source:

 www.ifcn.info/uploadfiles/documents/2015/Using_tES_devices_as_DIY_FINAL_13Dec15.pdf

 
 
 
 
 

IFCN