Milestone: Study protocol for the first TPS-Parkinson’s trial in the USA published
Parkinson's disease is not only the second most prevalent neurodegenerative disease after Alzheimer's disease, but also the fastest growing. With the number of cases steadily increasing, there is an urgent need for innovative therapeutic approaches.
Scientists at the world-renowned Spaulding Rehabilitation Hospital - Harvard Medical School have published a study protocol1 for the first TPS-based Parkinson’s trial2 in the USA investigating the effects of Transcranial Pulse Stimulation (TPS) on the overall symptom improvement in patients with Parkinson’s disease.
Millions of people affected - major challenges for healthcare systems
Despite the enormous efforts of foundations and research institutions around the world, there is still no causal treatment for Parkinson's disease. However, the disease can often be well controlled for years with medication and therapies. Typical motor symptoms include movement disorders such as tremors, impaired movements, muscle stiffness (rigor) and balance disorders. Non-motor symptoms may include depression, sleep disturbances, olfactory disorders, speaking difficulty and swallowing.
According to current estimates, around 10 million people worldwide are affected by Parkinson's disease. The number of patients is expected to increase significantly in the coming decades, posing immense challenges for healthcare systems.
Study protocol for a TPS pilot study in patients with Parkinson's disease in the USA
TPS is a treatment option for patients with Alzheimer's dementia that can be used in addition to standard therapy. In recent years, however, TPS research has expanded to include other neurological diseases such as Parkinson's disease.
To explore the potential effects of TPS on the symptoms of Parkinson's disease, a study protocol1 has been published for a pilot study2 involving 14 patients at the Spaulding Rehabilitation Hospital, an affiliation of Harvard Medical School. Under the direction of Prof. Felipe Fregni, a leading expert in non-invasive brain stimulation, the researchers will investigate whether personalized TPS can improve motor and non-motor Parkinson's symptoms. Upon completion of the pilot study, the next steps will be determined, and the results will be reported as soon as they are available.
1Gianlorenço, A. C., Camargo, L., Fernandes, E. B., Pichardo, E., Yeh, H. J., Hazer-Rau, D., Storz, R., & Fregni, F. (2025). Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease. Bioengineering, 12(7), 773.https://doi.org/10.3390/bioengineering12070773
2 Clinical Trials.gov.Parkinson's Disease: Overall Symptoms Improvement With Transcranial Pulse Stimulation (TPS). NCT06676995 https://clinicaltrials.gov/study/NCT06676995
