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Effects of Multisensory Stimulation on Consciousness in Patients with Acute Stroke

A Randomized Controlled Trial of Multisensory Stimulation for Disorders of Consciousness after Acute Stroke - MS-DOC Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061422
Enrollment
96
Registered
2026-05-01
Start date
2028-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

In addition to standard rehabilitation, multisensory stimulation (visual, auditory, olfactory, gustatory, tactile, kinesthetic, proprioceptive, and somatosensory) will be administered for 15 minutes p
from the following day onward, it will be provided twice daily (morning and afternoon), five days per week. Standard rehabilitation will be administered.

Sponsors

Nagasaki University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients admitted to the Stroke Center of Nagasaki University Hospital between the date of institutional approval and March 31, 2028. 2.Patients who meet a Glasgow Coma Scale (GCS) score of 3 to 12 as assessed by a physician at admission. 3.Patients with supratentorial cerebral infarction. 4.Patients aged 18 years or older who have received a full explanation of the study and for whom written informed consent has been obtained from a legally authorized representative based on their free will and sufficient understanding.

Exclusion criteria

Exclusion criteria: 1.Patients with pre-existing disorders of consciousness (DOC) prior to admission. 2.Patients with an implanted cardiac device, such as a pacemaker. 3.Patients with hemodynamic instability. 4.Patients with a history of stroke or other neurological diseases. 5.Exclude individuals with a known allergy to citrus essential oils, those with a history of dermatitis or respiratory symptoms induced by essential oil use, and those with severe bronchial asthma. 6.Rehabilitation therapy exceeding 5 units per day during the multisensory stimulation intervention period. 7.Patients deemed inappropriate for participation in the study by the principal investigator.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the change in the total score of the Coma Recovery Scale-Revised (CRS-R) from hospital day 2 (baseline) to day 7.

Secondary

MeasureTime frame
Secondary outcomes include:Change in the CRS-R total score from baseline to day 7, Changes in CRS-R subscale scores, Changes in diagnostic category of consciousness, Changes in Japan Coma Scale (JCS), Glasgow Coma Scale (GCS), and National Institutes of Health Stroke Scale (NIHSS) scores from baseline to days 7 and 14, Occurrence of adverse events.

Countries

Japan

Contacts

Public ContactYeonghee Lee

Nagasaki University Hospital Rehabilitation Department

yeong-lee@nagasaki-u.ac.jp0958197258

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026