vercise dbs dystonia registry protocol (Boston Scientific Corporation)

About

News

Press Release

Team

Advisors

Partners

Contact

Bioz Stars

Bioz vStars

Buy from Supplier

Structured Review

Boston Scientific Corporation vercise dbs dystonia registry protocol
Vercise Dbs Dystonia Registry Protocol, supplied by Boston Scientific Corporation, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
https://www.bioz.com/product/vercise+dbs+dystonia+registry+protocol/vercise+dbs+dystonia+registry+protocol/pmc11432838__pone__0303381__s002-346-42-28
Average 90 stars, based on 1 article reviews

vercise dbs dystonia registry protocol - by Bioz Stars, 2026-09

90/100 stars

Images

other:

Article Title: Real-world outcomes of Deep Brain Stimulation for dystonia treatment: Protocol for a prospective, multicenter, international registry
Article Snippet: • Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) • Global Dystonia Rating Scale (GDS) • Montreal Cognitive Assessment (MoCA) • Resource Utilization Inventory (RUI) (only for patients without Pocket Adaptor) Boston Scientific Vercise DBS Dystonia Registry Protocol Page 32 of 78 • Short Form Health Survey-36 (SF-36 v2) or Short Form Health Survey-10 (SF-10v2) (only for patients without Pocket Adaptor) • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Subjects will also be asked about any adverse events since their last study visit (if any).

Article Title: Real-world outcomes of Deep Brain Stimulation for dystonia treatment: Protocol for a prospective, multicenter, international registry
Article Snippet: The communication requirements for reporting to BSC are described in Table 20.4-1 Boston Scientific Vercise DBS Dystonia Registry Protocol Page 67 of 78 The investigator must report Adverse Device Effects, Serious Adverse Events (regardless of relationship to device hardware, stimulation and/or procedure), Unanticipated Serious Adverse Device Effects, and Device Deficiencies for each subject from the time of Information Consent through the end of study participation.

Article Title: Real-world outcomes of Deep Brain Stimulation for dystonia treatment: Protocol for a prospective, multicenter, international registry
Article Snippet: It is important that the Investigator Boston Scientific Vercise DBS Dystonia Registry Protocol Page 52 of 78 and relevant study personnel are available during on-site monitoring visits or audits and that sufficient time is devoted to the process.

Article Title: Real-world outcomes of Deep Brain Stimulation for dystonia treatment: Protocol for a prospective, multicenter, international registry
Article Snippet: Table of Tables Table 9-1: Inclusion Criteria ................................................................................................... 25 Table 9-2: Exclusion Criteria .................................................................................................. 25 Table 11-1: Data Collection Schedule .................................................................................... 28 Table 11-2: Data Assessment.................................................................................................. 29 Table 11-3: Source Documentation Requirements ................................................................. 37 Table 20.2-1: Safety Definitions ..............................................................................................60 Table 20.3-1: Criteria for Assessing Relationship of Study Device or Procedure to Adverse Event .................................................................................................................... 64 Table 26-1: Abbreviations ...................................................................................................... 75 Table 26-2: Definitions ........................................................................................................... 77 Boston Scientific Vercise DBS Dystonia Registry Protocol Page 14 of 78 4.

Article Title: Real-world outcomes of Deep Brain Stimulation for dystonia treatment: Protocol for a prospective, multicenter, international registry
Article Snippet: Boston Scientific Vercise DBS Dystonia Registry Protocol Page 48 of 78 • Provide his/her qualifications and experience to assume responsibility for the proper conduct of the study and that of key members of the center team through up-to-date curriculum vitae or other relevant documentation and disclose potential conflicts of interest, including financial, that may interfere with the conduct of the clinical study or interpretation of results.

Article Title: Real-world outcomes of Deep Brain Stimulation for dystonia treatment: Protocol for a prospective, multicenter, international registry
Article Snippet: Data Collection, Processing, and Review .............................................................. 41 Boston Scientific Vercise DBS Dystonia Registry Protocol Page 10 of 78 13.1.1.

Article Title: Real-world outcomes of Deep Brain Stimulation for dystonia treatment: Protocol for a prospective, multicenter, international registry
Article Snippet: Examples of source documents include, but are not limited to the following: • Informed consent form and consent process documentation; • Documentation of medical history components; • Medical records from clinical visits (i.e. progress notes, etc.) and operative procedures (i.e. Operative Report, etc.); • Study-specific source document worksheets (if applicable); Boston Scientific Vercise DBS Dystonia Registry Protocol Page 37 of 78 • Laboratory/Test Results, if applicable; • Neuropsychological and psychiatric tests results; • Questionnaires such as SF-36v2, etc.

Review

vercise dbs dystonia registry protocol (Boston Scientific Corporation)

Structured Review

Images

Related Articles

other:

Similar Products

Image Search Results