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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03543280
Other study ID # 6787
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 23, 2018
Est. completion date February 2019

Study information

Verified date February 2018
Source University Hospital, Strasbourg, France
Contact Izzie Jacques NAMER, MD, PhD
Phone 33 3 88 12 75 50
Email Izzie.Jacques.NAMER@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

At present there is no consensus for post-stroke imaging except for the realization of early cerebral CT at 24 hours post-thrombolysis. The use of cerebral perfusion scintigraphy would predict the course of a stroke. Indeed, it has been shown that a good perfusion is linked to a good evolution of the neurological deficit. This test is used routinely to evaluate cerebral perfusion in patients with stroke. This technique was also used to study the mechanisms of post-stroke aphasia and to highlight neuronal disconnections after stroke, a reflection of the functioning of neural networks.

Neuropsychological tests are almost always done at 3 months. Fatigue is studied: PSF scale at 3 months, 6 months and 2 years. Research needs to be continued in this area because the pathophysiology remains unknown and the symptoms are disabling for patients. Using cerebral perfusion imaging would bring elements of understanding of this mechanism and ultimately improve the management of patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients: 18 to 60 years old at the initial diagnosis

- Admission for transient ischemic attack, stroke, dissection, TVC

- RANKIN less than or equal to 2

- Neuropsychological tests at +3 months: MoCA> 26 (to eliminate cognitive deteriorations too important for the good realization of the battery)

- Absence of psychiatric history

- Absence of psychotropic medication

- No history of stroke

- No complaint of pre-stroke fatigue

- Having signed the consent form

Exclusion Criteria:

- Impossibility of giving the subject or his family enlightened information (subject in emergency situation, difficulties in understanding the subject, etc.)

- Subject under the protection of justice

- Subject under guardianship or curatorship

- Refusal of the patient to participate in the study

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service de Biophysique et de Médecine Nucléaire Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate fatigue symptoms in stroke patients After the period following a stroke: 1 month