An interventional study of Transcranial pulse stimulation (TPS) in Alzheimer Disease, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo.
Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolith™ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Experimental: Neuronavigation system guided halocranial application of focused sound wave pulses, using the Storz Neurolith™ equipment.
Other: Transcranial pulse stimulation (TPS)
Neuronavigation system guided halocranial application without sound waves pulses, using the Storz Neurolith™ sham equipment, prepared to block the sound waves.
Other: Transcranial pulse stimulation (TPS)
Clinical treatment consists in ten sessions of neuronavigation system guided halocranial application of 6000 focused sound wave pulses, with energy flux density of 0.25 mJ/mm2, depth of focus of 5 cm and useful energy between 4 to 6 cm, frequency of 4 Hz, total energy applied will be 50 Joules, for it will be used the Storz Neurolith™ equipment.
Cognitive Functions
Cognitive functions, using Alzheimer's Disease Assessment Scale (ADAS-Cog)
Time frame: Baseline and up to one, three, six and twelve months from intervention
Plan to share: Undecided — Individual Participant Data (IPD) may be shared in the future under suitable request and justification to principal investigator.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital