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Principal Investigator: Bashar W Badran
Organization: MEDICAL UNIVERSITY OF SOUTH CAROLINA
Fiscal Year: 2023
Award: $637,973
Funding agency: National Institute on Deafness and Other Communication Disorders
ABSTRACT
COVID exposed the critical need for new and improved treatment interventions for chemosensory (i.e. smell and
taste) dysfunction. Evidence indicates that COVID-related smell loss (SL) often endures well past recovery of
the initial infection and is highly associated with other long COVID neuropsychiatric symptoms including
impairments in mood, sleep, and cognition. To date, there are few interventions available to treat COVID-related
persistent SL and its related impairments. While smell/olfactory training (ST) has emerged as a widely
prescribed, front-line treatment for COVID-related persistent SL, rigorous study is required to determine its
efficacy in long COVID. Moreover, given that ST is a lengthy treatment, requiring 12 weeks or longer of training,
and is associated with slow improvement, non-compliance, drop-out, and modest effect size, additional study of
adjunctive methods to improve its efficacy and speed of recovery are warranted. Here we propose the first study
to investigate combinatorial trigeminal nerve stimulation (TNS) and ST in the treatment of post-COVID persistent
SL and associated deficits in mood, sleep and cognitive impairment. Our previous work suggests that TNS, an
easy-to-use and very safe form of non-invasive brain stimulation, increases olfactory sensitivity and has the
potential to improve other symptoms of long COVID including mood, daytime sleepiness, and attention.
Therefore, we will conduct a larger at-home, randomized, controlled trial of ST and determine whether TNS
enhances the effects of ST in adults with COVID-related persistent SL. Our primary objectives are 1) to determine
the efficacy of ST, compared to any natural gain in function, on olfactory-specific deficits (active ST versus sham
ST), 2) to determine the TNS-enhanced effects of ST on olfactory-specific deficits (active TNS+ST versus active
ST), and 3) to determine if TNS+ST, compared to ST, is also more efficacious in the treatment of other
impairments (i.e. mood, sleep, and cognitive) associated with both SL and long COVID. While this research is
focused on COVID-related persistent SL, the results will provide the necessary information to extend the study
and use of ST and TNS to address wider chemosensory dysfunction. This line of investigation has the potential
to make a substantial impact on how chemosensory dysfunction is treated and in turn significantly improve the
current standard of care.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><21+ years old><Acceleration><Address><Adult><Adult Human><After Care><After-Treatment><Aftercare><Anosmia><Area><Attention><Brain><Brain Nervous System><COVID><COVID anosmia><COVID associated anosmia><COVID related anosmia><COVID smell loss><COVID therapy><COVID treatment><COVID-19><COVID-19 anosmia><COVID-19 associated anosmia><COVID-19 associated smell loss><COVID-19 related anosmia><COVID-19 smell loss><COVID-19 virus><COVID-related smell loss><COVID19><COVID19 virus><CV-19><CV19><Causality><CoV disease><CoV-2><CoV2><Cognition><Cognitive><Cognitive Disturbance><Cognitive Impairment><Cognitive decline><Cognitive function abnormal><Communication><Cranial Nerve V><Detection><Development><Disturbance in cognition><Dropout><Drowsiness><Dysfunction><Electric Stimulation><Electrical Stimulation><Encephalon><Etiology><Evidence based intervention><Evidence based practice><Evidence based treatment><Fifth Cranial Nerve><Functional disorder><Gustation><Healthcare><Home><Human><Impaired cognition><Impairment><Infection><Intervention><Intervention Strategies><Investigation><Long COVID><Long COVID-19><Long coronavirus disease><Long coronavirus disease 2019><Mental Health><Mental Hygiene><Methods><Modern Man><Moods><NIDCD><National Institute on Deafness and Other Communication Disorders><Natural regeneration><Nerve Cells><Nerve Unit><Nervus Trigeminus><Neural Cell><Neurocyte><Neurons><Olfaction><Pain Free><Paraosmias><Physiopathology><Psychological Health><Psychophysics><Publishing><Qualifying><Randomized, Controlled Trials><Recovery><Regeneration><Research><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV2><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Science><Sensory><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome related corona virus 2><Sleep><Smell><Smell Perception><Somnolence><Speed><Strategic Planning><Symptoms><Taste><Taste Perception><Training><Treatment Efficacy><Trigeminal Nerve><Trigeminal System><Trigeminal nerve structure><Work><Wuhan coronavirus><adulthood><anosphrasia><causation><chronic COVID><chronic COVID-19><chronic novel coronavirus disease 2019><cognitive dysfunction><cognitive function><cognitive loss><combinatorial><corona virus disease><corona virus disease 2019><coronavirus disease><coronavirus disease 2019><coronavirus disease 2019 virus><coronavirus disease 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disease><longterm coronavirus disease 2019><loss of smell><nCoV2><neural control><neural regulation><neuromodulation><neuromodulatory><neuronal><neuropsychiatric disease><neuropsychiatric disorder><neuropsychiatric symptom><neuroregulation><non-compliance><non-compliant><non-invasive brain stimulation><noncompliance><noncompliant><noninvasive brain stimulation><novel><odor perception><olfactory loss><olfactory perception><parosmia><pathophysiology><physical conditioning><physical health><post COVID syndrome><post COVID-19 syndrome><post acute COVID syndrome><post acute COVID-19><post acute COVID-19 syndrome><post acute SARS-CoV-2><post acute coronavirus disease 2019><post acute coronavirus disease 2019 syndrome><post acute coronavirus disease syndrome><post acute severe acute respiratory syndrome coronavirus 2><post coronavirus disease 2019 syndrome><post coronavirus disease syndrome><post treatment><post-COVID><post-COVID-19><post-acute phases of COVID-19><post-coronavirus disease 2019><psychophysical><quality of sleep><randomized control trial><reduced smell><regenerate><response><sleep quality><sleepiness><smell loss associated with COVID-19><standard of care><symptomatology><taste processing><taste response><therapeutic efficacy><therapy efficacy><trigeminal>