NCT06032585

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

September 4, 2023

Last Update Submit

July 21, 2025

Conditions

Keywords

Transcranial ultrasoundSubstantia nigra

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation

    7-10 (retrospective)

Study Arms (1)

Patients with parkinsonism

Parkinsonism incl. tremor, parkinsons, atypical parkinsons

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Newly diagnosted patients with parkinsonism between 2013-2017 at our centre

You may qualify if:

  • Patients with parkinsonism or essential tremor who came into contact with our clinic before 2017
  • Satisfactory transcranial bone window
  • Previous TU (clinical indication)

You may not qualify if:

  • No transcranial bone window

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne Univ Hospital

Malmo, Skåne County, 20502, Sweden

Location

MeSH Terms

Conditions

Parkinsonian DisordersTremorDementia

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 13, 2023

Study Start

February 8, 2024

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations