
The Medical Device Production Transfer Process
A production transfer is a common occurrence in the medical device industry. However, what often...
Transcranial electrical stimulation or TES is a broad term encompassing all procedures involving the application of low intensity, weak electrical stimulation applied at specific locations of the brain or spinal cord. This is essentially a non-invasive technique and there is a number of ways TES can be administered, including the use of wearable devices placed on or just under the skin. Insulated leads are responsible for delivering the low-intensity current.
The therapeutic applications for Transcranial electrical stimulation have been limited to chronic neurological conditions. This kind of treatment can be referred to as palliative care. Conditions such as chronic pain, depression, epilepsy, Parkinson’s, Alzheimer’s, some stroke-related conditions such as paralysis, and any neurological condition involving the misfiring of neurons in the central nervous system can benefit from TES. TES helps manage chronic neurological conditions, that’s why it is used to improve the quality of life of affected individuals. A key factor in influencing patient outcomes.
The location or site of placement of electrical leads determines what kind of mediatory effect is produced. The therapeutic applications for Transcranial electrical stimulation can either utilize a direct current – called a transcranial Direct Current Stimulation (tDCS) or an alternating one. The condition to be treated is diagnosed by a specialized physician who determines where, when, and how long the TES device can be used. For example, the application of weak electrical stimulus between 1 to 2 mA, through leads placed on the scalp, has the potential to block pain sensation – when treating chronic pain. When treating someone with a speech impediment or partial paralysis due to a stroke, the area of application will vary. Interestingly, the site of application can even influence mood and memory, which is useful when treating stroke-related conditions, or Parkinson’s or Alzheimer’s.
TES wearables comprise a battery, control mechanisms, leads (or stimulators), and cables. The device could be mounted using head-gear consisting of a strap or adhesive tapes. The device can also be implanted in the subcutaneous layer of the skin, either in the back or the abdomen region and leads are placed strategically along the spinal cord or the scalp.
Numerous studies such as the one conducted by Bikson and his colleagues have reported that there are no adverse effects associated with the use of TES. A high quality TES device is one that’s manufactured with under strict cGMP standards and uses completely biocompatible materials for the manufacture of each component in contact with the human body.
Unlike other treatments, Transcranial electrical stimulation(or tDCS) being non-invasive, is cost-effective and safe to use under medical supervision. For those considering undergoing TES, qualified medical prescription is mandatory, to avoid unnecessary medical complications. It is to be noted that the field of neuro-stimulation is a growing one, with new research pointing to clearer dose-response, structure-function relationships, coming out every year, physicians use TES after extensive consideration and only under specific conditions.