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Olfactory Stimulation in Severe Brain Injury

NCT05747170 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-03-20

No results posted yet for this study

Summary

The management of patients with disorders of consciousness (DoC) represents a topic of great importance and topicality in the medical-scientific field because of the complexity and extent of associated disabilities and the difficulty in identifying effective therapeutic approaches. Despite significant advances in neuroscience, much remains to be elucidated about the mechanisms that regulate consciousness, and which of these to act on to stimulate plasticity and thus promote responsiveness and functional recovery in patients. Evidence on treatments that promote arousal and communication skills in individuals with DoC is still limited.

Among the possible interventions proposed in the literature, sensory stimulation would act by stimulating synaptic plasticity, counteracting the sensory deprivation to which these patients are exposed.

Published studies on the topic have produced results that are not unique and difficult to compare across different stimulation protocols (content, intensity, frequency, modality), settings and patient populations.

Conditions

  • Disorder of Consciousness

Interventions

OTHER

Olfactory sstimulation

The odors being tested (natural odor, neutral odor, chemical odor) are part of the 40 fragrances made by International Flavors and Fragrances (IFF) and each is contained in an approximately 15-mL glass bottle. The selected odors will be administered using a small paper strip (15 cm length and 0.7 cm width) that will be soaked in the selected odor and placed under the subject's nose at a minimum distance to prevent direct contact of the strip with the skin; the strip will be moved alternately from one nostril to the other. Stimulation will have, for each odor the duration of 5 minutes. It will always be carried out within the same time slot (between 8:00 am and 4:00 pm) for 5 consecutive days for 2 weeks. Before and after the administration of each odor, a neutral odor (water) will be administered as a control in the same manner as described above. The sequence of odor administration will be randomized according to a computer-generated sequence.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Luca Padua, MD, phD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-04-30
Completion
2024-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05747170 on ClinicalTrials.gov