Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease
Parkinson’s Disease (PD) is a progressive neurodegenerative disorder marked by motor and non-motor symptoms, including cognitive decline, mood disturbances, and sensory deficits. While dopaminergic treatments remain the gold standard, they present long-term side effects and limited impact on non-mot...
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MDPI AG
2025-07-01
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| Series: | Bioengineering |
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| Online Access: | https://www.mdpi.com/2306-5354/12/7/773 |
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| author | Anna Carolyna Gianlorenço Lucas Camargo Elayne Borges Fernandes Elly Pichardo Huan Jui Yeh Dilana Hazer-Rau Rafael Storz Felipe Fregni |
| author_facet | Anna Carolyna Gianlorenço Lucas Camargo Elayne Borges Fernandes Elly Pichardo Huan Jui Yeh Dilana Hazer-Rau Rafael Storz Felipe Fregni |
| author_sort | Anna Carolyna Gianlorenço |
| collection | DOAJ |
| description | Parkinson’s Disease (PD) is a progressive neurodegenerative disorder marked by motor and non-motor symptoms, including cognitive decline, mood disturbances, and sensory deficits. While dopaminergic treatments remain the gold standard, they present long-term side effects and limited impact on non-motor symptoms. Transcranial Pulse Stimulation (TPS) has emerged as a promising adjunct therapy in neurological and psychiatric conditions, but its effects in PD remain underexplored. This open-label, single-arm trial protocol involves 14 PD participants and outlines a personalized 12-session treatment approach combined with a homogeneously distributed TPS intervention among patients with PD. The approach addresses the subject’s most prominent symptoms, as identified through validated clinical assessments, encompassing domains related to both motor and non-motor symptoms. Over 2.5 months, besides the intervention sessions, the 14 participants will undergo an MRI brain scan, a baseline assessment, a post-treatment assessment, and a 1-month follow-up assessment. The study aims to determine whether personalized TPS is a feasible and safe intervention and whether it improves PD symptoms across multiple functional domains. This study represents the first structured attempt to evaluate a multimodal, personalized TPS intervention in patients with PD. It addresses gaps in current treatment approaches and may support the development of future strategies for integrated, symptom-targeted neuromodulation. |
| format | Article |
| id | doaj-art-11d65d3f48d44173a80abefd8d5780c2 |
| institution | DOAJ |
| issn | 2306-5354 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Bioengineering |
| spelling | doaj-art-11d65d3f48d44173a80abefd8d5780c22025-08-20T03:13:41ZengMDPI AGBioengineering2306-53542025-07-0112777310.3390/bioengineering12070773Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s DiseaseAnna Carolyna Gianlorenço0Lucas Camargo1Elayne Borges Fernandes2Elly Pichardo3Huan Jui Yeh4Dilana Hazer-Rau5Rafael Storz6Felipe Fregni7Spaulding Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02115, USASpaulding Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02115, USASpaulding Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02115, USASpaulding Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02115, USASpaulding Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02115, USASTORZ MEDICAL AG, 8274 Tagerwilen, SwitzerlandSTORZ MEDICAL AG, 8274 Tagerwilen, SwitzerlandSpaulding Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA 02115, USAParkinson’s Disease (PD) is a progressive neurodegenerative disorder marked by motor and non-motor symptoms, including cognitive decline, mood disturbances, and sensory deficits. While dopaminergic treatments remain the gold standard, they present long-term side effects and limited impact on non-motor symptoms. Transcranial Pulse Stimulation (TPS) has emerged as a promising adjunct therapy in neurological and psychiatric conditions, but its effects in PD remain underexplored. This open-label, single-arm trial protocol involves 14 PD participants and outlines a personalized 12-session treatment approach combined with a homogeneously distributed TPS intervention among patients with PD. The approach addresses the subject’s most prominent symptoms, as identified through validated clinical assessments, encompassing domains related to both motor and non-motor symptoms. Over 2.5 months, besides the intervention sessions, the 14 participants will undergo an MRI brain scan, a baseline assessment, a post-treatment assessment, and a 1-month follow-up assessment. The study aims to determine whether personalized TPS is a feasible and safe intervention and whether it improves PD symptoms across multiple functional domains. This study represents the first structured attempt to evaluate a multimodal, personalized TPS intervention in patients with PD. It addresses gaps in current treatment approaches and may support the development of future strategies for integrated, symptom-targeted neuromodulation.https://www.mdpi.com/2306-5354/12/7/773Parkinson’s diseasebrain stimulationtranscranial pulse stimulation |
| spellingShingle | Anna Carolyna Gianlorenço Lucas Camargo Elayne Borges Fernandes Elly Pichardo Huan Jui Yeh Dilana Hazer-Rau Rafael Storz Felipe Fregni Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease Bioengineering Parkinson’s disease brain stimulation transcranial pulse stimulation |
| title | Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease |
| title_full | Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease |
| title_fullStr | Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease |
| title_full_unstemmed | Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease |
| title_short | Study Protocol: Investigating the Effects of Transcranial Pulse Stimulation in Parkinson’s Disease |
| title_sort | study protocol investigating the effects of transcranial pulse stimulation in parkinson s disease |
| topic | Parkinson’s disease brain stimulation transcranial pulse stimulation |
| url | https://www.mdpi.com/2306-5354/12/7/773 |
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