TRANSPARK_LONG: The Diagnostic Value of Early Transcranial Ultrasound in Patients With Extrapyramidal Diseases in a Swedish Population

Dementia Clinical Trial

Official title:

TRANSPARK_LONG: The Diagnostic Value of Early Transcranial Ultrasound in Patients With Extrapyramidal Diseases in a Swedish Population: an Evaluation in the Form of a Retrospective Cohort Study With a Long Follow-up Time

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032585
• Other study ID #: Dnr 2022-06697-01
• Status: Recruiting
• Start date: February 8, 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Region Skane
• Contact: Markus Stiehm
• Phone: +4640336379
• Email: Markus.Stiehm[@]skane.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Popular science summary of the project The purpose of the study is to investigate in a Swedish population how well the investigators' previous ultrasound findings match the final diagnosis (PD, APS or ET) after a particularly long follow-up time, which greatly increases the certainty that the diagnosis does not change more and is thus correct. Furthermore, the investigators want to study whether the initial ultrasound findings have changed during the control interval and whether measurement results regarding the diameter in one of the fluid-filled rooms in the brain (third ventricle) can be correlated with the development of cognitive impairment or dementia later in the course of the disease. For this, this study have got ethical permission to go into the patients' medical records and to call a subgroup back to the clinic to be able to do a new examination and a memory test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with parkinsonism or essential tremor who came into contact with our clinic before 2017

• Satisfactory transcranial bone window

• Previous TU (clinical indication)

Exclusion Criteria:

• No transcranial bone window

Related Conditions & MeSH terms

• Dementia
• Parkinsonian Disorders
• Parkinsonism
• Tremor

Locations

Country	Name	City	State
Sweden	Skåne Univ Hospital	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation	Is hyperechogenicity of substantia nigra at mesencephal plane (measured bilaterally in mm2 by transcranial b-mode sonography correlated with a high percentage of patients with classical Parkinsons Disease in contrast to atypical parkinsonism patients?	over 7-10 yrs
Secondary	Correlation	Is 3rd ventricle atrophy (measured in mm by b-mode transcranial sonography) correlated with a high % of demented patients in the cohort?	7-10 (retrospective)