2.3. Randomization Procedure and Groups Description
paresthesia, SAH
PARESTHESIA
Randomization was conducted on the activation of the trigeminal nerve TENS device during the initial management of the intensive care unit. It was performed using a randomization list predefined by the study methodologist and provided to the clinical trial personnel of the Poitiers University Hospital. Eligible patients were randomly assigned to either trigeminal nerve stimulation (TNS group) or sham (sham group) in a 1:1 ratio. Both patients and evaluators were blinded to the randomization results.TENS of the trigeminal nerve, active or sham (no stimulation) depending on the randomization arm, was applied bilaterally from day 1 (D1) to day 10 (D10).The electrodes were positioned at the innervation territory of the supra-trochlear and supra-orbital nerves, which are terminal branches of the ophthalmic division of the trigeminal nerve (The stimulation parameters for the two groups were as follows:For non-sedated patients, the stimulation intensity threshold was adjusted according to the sub-clinical threshold of the feeling of paresthesia for each patient. Before using any medical device in the study, for the activity which was not known by the clinician (active or sham), the clinician determined the maximum threshold of each patient before they felt paresthesia using a regular TENS eco 2 (schwa-medico, Rouffach, France) available at the center. This threshold allowed direct stimulation of the trigeminal nerve without causing paresthesia in the patients, thereby guaranteeing that both the patient and clinician would remain blinded. Sham therapy was delivered using a specific device that looks and works similarly by displaying the current intensity, but this device does not deliver any electrical stimulation. The determined maximum threshold was not significantly different between the TENS (9.6 ± 2.7 mA) and the sham groups (11.4 ± 1.5 mA, For sedated patients, the stimulation threshold was maintained at 20 mA, except for patients who were scheduled to stop sedation before the 10th day of the TENS/sham application. For these specific patients, lower stimulation thresholds were used in order to maintain double blinding after waking up the patient. The determined maximum threshold was not significantly different between the TENS (4.9 ± 2.9 mA) and sham groups (4.3 ± 2.2 mA, Aside from this specific external neurostimulation procedure, both the TNS and the sham groups received standardized and comparable aneurismal SAH treatment.