About VNS

VNS uses brief electrical impulses to stimulate areas of the brain that are important for controlling emotions and behavior.

An implantable VNS device has been approved by the FDA to treat epilepsy, chronic recurrent depression, migraines, and cluster headaches. Both implanted and wearable VNS devices have been studied in a small number of individuals with PWS with a significant reduction in both the number and severity of temper outbursts.

The potential benefits of VNS in people with PWS were first demonstrated using a surgically implanted VNS device in three adults with PWS. While no effects on hyperphagia or weight were observed, improvements in temper outbursts were seen in two of three adult participants. The participant who showed no improvement did not have a prior history of temper outbursts. The two participants whose behavior improved asked to continue with the VNS after the study finished, and in an informal follow-up eight years later both individuals reported continuing benefits and no unexpected side effects. 

A second clinical trial using transcutaneous vagus nerve stimulation (tVNS) has also shown efficacy. The external device was worn for four hours each day with an electrode in the left ear to stimulate the auricular branch of the vagus nerve. Temper outbursts improved significantly in 4 out of 5 participants after six to nine months of tVNS. (Manning et al., PLOS One. 2019). By the end of the 9-month treatment period, significant reductions in the number of temper outbursts were observed to the extent that participants that responded to the tVNS treatment had no outbursts or, at the most, the very occasional outburst. No significant side effects were observed. 

Who Can Participate in the Trial?

• People with PWS ages 10-40 and their caregivers
• Have a history of disruptive behaviors over the past 6 months
• Medications have been stable for the past 90 days
• Not currently participating in another clinical trial (medication or behavioral)

Participants who complete the trial will have the option of enrolling in an extension study so they may continue to use the device!

You can learn more about the VNS4PWS trial in this short webinar: 

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