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Trial record 2 of 629 for:    neurologic | COVID-19

Post COVID-19 Neurologic Symptoms : a Somatic Spectrum Disorder ? (SOMATiC) (SOMATiC)

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ClinicalTrials.gov Identifier: NCT04889313
Recruitment Status : Active, not recruiting
First Posted : May 17, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de Saint-Denis

Brief Summary:
A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms.

Condition or disease
COVID-19

Detailed Description:
A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms. The study includes consecutive patients referred for neurology consultation because of chronic neurologic symptoms after the acute phase of COVID-19. Data are collected with medical record and by phone interview. It consisted of a semi-structured interview followed by hetero-assessed scales. A positive diagnosis of SSD was established with all the following criteria: a PHQ15 score greater than or equal to 12 (criterion A); an SSD12 score greater than or equal to 23 (criterion B); an evolution of symptoms greater than or equal to four weeks for criterion C. To complete the DSMV criteria, the investigators assessed the presence of indirect argument in favor of SSD diagnosis : a traumatic experience of the initial episode collected during the interview, post-traumatic stress disorder measured by the IES-R scale, a psychiatric history collected during the interview, significant alexithymia measured by the TAS 20 scale, traits of pronounced perfectionism with the scale adapted by Cox et al. from HF MPS, chronic fatigue syndrome as described after viral infections with the SOFA scale, functional disorders prior to infection with SARS-CoV-2, a former and/or current medical nomadism, a significant consumption of care. The quality of life is measured by the WHOQOL-BREF scale, anxious and/or depressive symptoms measured by the HAD scale, and sleep disorders assessed by the ISI scale .

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Neurologic Symptoms After Non-severe COVID-19 : Analysis and Diagnosis Assessment of Somatic Spectrum Disorder
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021



Primary Outcome Measures :
  1. A positive diagnosis of SSD [ Time Frame: 30 minutes ]
    all the following criteria: a PHQ15 score greater than or equal to 12 (criterion A); an SSD12 score greater than or equal to 23 (criterion B); an evolution of symptoms greater than or equal to four weeks for criterion C



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients referred for neurology consultation to a referent neurologist in our center from may 2020 to may 2021
Criteria

Inclusion Criteria:

  • adults (18 years-old or older)
  • having had a mild or moderate COVID-19 managed on an outpatient basis during the acute phase of the infection
  • COVID-19 virologically confirmed or suspected on the basis of suggestive symptoms
  • spontaneously consulting for post-COVID-19 symptoms and referred for neurological advice in our center
  • with neurological clinical evaluation concluding that there is no differential diagnosis.

Exclusion Criteria:

  • patients who were hospitalized during the acute phase of the infection
  • suspected de novo neurological pathology unrelated to COVID-19
  • patient refusal to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04889313


Locations
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France
Centre Hospitalier de Saint-Denis
Saint-denis, Ile De France, France, 93200
Sponsors and Collaborators
Centre Hospitalier de Saint-Denis
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Responsible Party: Centre Hospitalier de Saint-Denis
ClinicalTrials.gov Identifier: NCT04889313    
Other Study ID Numbers: CHSD_NEURO_01
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier de Saint-Denis:
Somatic Symptom Disorder
COVID-19
Neurologic symptoms
Additional relevant MeSH terms:
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Neurologic Manifestations
Nervous System Diseases