A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms

Phase 4

Completed

• Conditions: Parkinsonian Syndromes
• Interventions: Procedure: DaTSCAN SPECT imaging

• Registration Number: NCT00382967
• Lead Sponsor: GE Healthcare

Brief Summary

Patients come to their doctor showing possible symptoms of a movement disorder. It is possible that these symptoms may get worse over time. There is more than one disease that can cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. On the other hand the correct treatment for Parkinson´s Disease is different from the correct treatment for Essential Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can affect the way the doctor treats these patients and whether it can affect their quality of life directly.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-29
• Study First Submitted QC: 2006-09-29
• Study Start: 2006-10
• Study First Posted: 2006-10-02
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-05-14
• Results First Submitted QC: 2012-07-26
• Status Verified: 2012-08
• Results First Posted: 2012-08-29
• Last Update Submitted: 2012-08-29
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability.
• Onset of clinical manifestations within the last 5 years

Exclusion Criteria

• Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy or between Parkinson´s Disease and Multiple System Atrophy
• Subjects with an established/certain movement disorder clinical diagnosis
• Presence of known causes of tremor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Datscan Product	DaTSCAN SPECT imaging	-

Primary Outcome Measures

Name	Time	Method
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.	Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)	The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.

Secondary Outcome Measures

Name	Time	Method
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.	From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.	The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.

Trial Locations

Locations (1)

GE Healthcare; 🇫🇷 Velizy, France