Clinical trial of a take-home rehabilitation device for vestibular patients.

We have designed and built a small, non-invasive, safe, battery-driven, portable, head-mounted programmable device that patients will use to train at home (i.e., with the dosage / compliance recorded). Both control and intervention groups will be asked to perform current best practice rehabilitation, which are home-based exercises 5 times daily for a total of 30-40 min per day, with changes in exercises from week to week. After these exercises, both groups will perform the device or placebo intervention for 15 minutes. Patient's will be asked to perform these exercises for 6 months followed by a 6 month washout period. At the end of the 6 month washout period patients will again be asked to perform exercises with the device, but will change groups, i.e., if they were in the intervention group for the first 6 months they go into the placebo group for the second 6 months and vice versa. The second 6 months is also followed by a 6 month washout period. The intervention exercise consists of the patient rapidly turning their head leftwards by a small angle (i.e., a 5-10 degree turn), then slowly returning the head back to neutral, followed by a similarly rapid rotation rightwards. The patient’s task will be to visually track a moving laser dot target on the wall in front of them while they keep turning their head. The basis of incremental adaptation training is that tracking the target starts off easy and gradually gets harder for the patient. This approach has been shown to be more effective at increasing the vestibulo-ocular reflex response compared to tracking a stationary target while turning the head, i.e., a difficult task for vestibular patients. Patients will be educated by one of the researchers listed on our protocol to use the device during their first (baseline) session at our laboratory, In the test group, subjects will use the rehabilitation device at home for 15 minutes once daily performing the new incremental adaptation technique we developed. In the control group, subjects will also use the rehabilitation device at home for 15 minutes once daily; however, the device will project a stationary visual target, so that the training is identical to one of the exercises performed in current best practice. A log is automatically maintained on the device to record compliance, whereas patients must manually record their compliance to current best practice via diary. Patients will be asked to bring their diary with them to each monthly visit to our laboratory.