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

COVID-19 Clinical Trial

— SOMATiC  

Official title:

Neurologic Symptoms After Non-severe COVID-19 : Analysis and Diagnosis Assessment of Somatic Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889313
• Other study ID #: CHSD_NEURO_01
• Status: Completed
• Start date: April 22, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier de Saint-Denis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Neurologic Manifestations

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Denis	Saint-denis	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Saint-Denis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A positive diagnosis of SSD	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	30 minutes