Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05855369
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Trigeminal Nerve Stimulation (TNS) — DEVICE
    Non-invasive, pain-free, low-level electrical stimulation to the forehead to modulate the trigeminal nerve and enhance smell function through activation of the highly connected olfactory-intranasal trigeminal brain circuits.
  • Active Smell Training (ST) — OTHER
    Sniffing various higher intensity odorant chemicals while performing odor-related cognitive tasks. 16 odorant chemicals will be used for training including: 2 phenyl ethanol, eugenol, lemon, eucalyptus, cinnamon, peppermint, coffee, mandarin, lavender, vanilla, lilac, ginger, chocolate, thyme, banana, and bacon.
  • Placebo Smell Training (PBO) — OTHER
    Sniffing the same lower intensity odorant chemicals (i.e. N-butanol and 2-phenyl ethanol) over the course of the trial and performing no odor-related cognitive tasks.

Study Details

Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. This study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.

Key Dates

Start date
Oct 2, 2023
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
145 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Combination Trigeminal Nerve Stimulation (TNS) and active Smell Training (ST)
    30 minutes of once/day TNS and twice/day ST conducted 5 days/week for 12 weeks and a total of 60 stimulation and 120 smell training sessions
  • Active Comparator: Active Smell Training (ST)
    5 minutes of daily ST conducted twice/day, 5 days/week for 12 weeks and a total of 120 training session
  • Placebo Comparator: Placebo Smell Training (PBO)
    5 minutes of daily PBO conducted twice/day, 5 days/week for 12 weeks and a total of 120 training sessions

Primary Outcome Measure

Change in Psychophysical Olfactory Function from Baseline to 4 and 12 Weeks [ Time Frame: 2 times: 4 weeks, 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Bernadette Cortese, PhD
[email protected]
843-792-6922

Find similar trials in Charleston, SC

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Medical University of South Carolina· Charleston, SC

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