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

NCT04889313 | Completed

• 1 other identifier: CHSD_NEURO_01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Somatic Symptom Disorder; COVID-19; Neurologic symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

Centre Hospitalier de Saint-Denis

Saint-Denis, Île-de-France Region, 93200, France

Location

Related Publications (1)

• Kachaner A, Lemogne C, Dave J, Ranque B, de Broucker T, Meppiel E. Somatic symptom disorder in patients with post-COVID-19 neurological symptoms: a preliminary report from the somatic study (Somatic Symptom Disorder Triggered by COVID-19). J Neurol Neurosurg Psychiatry. 2022 Aug 25:jnnp-2021-327899. doi: 10.1136/jnnp-2021-327899. Online ahead of print.

  PMID: 36008115 DERIVED

MeSH Terms

Conditions

COVID-19; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 17, 2021
• Study Start: April 22, 2021
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)