UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061422 |
|---|---|
| Receipt number | R000069454 |
| Scientific Title | A Randomized Controlled Trial of Multisensory Stimulation for Disorders of Consciousness after Acute Stroke |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/30 22:17:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Multisensory Stimulation on Consciousness in Patients with Acute Stroke
Acronym
MS-DOC Trial
Scientific Title
A Randomized Controlled Trial of Multisensory Stimulation for Disorders of Consciousness after Acute Stroke
Scientific Title:Acronym
MS-DOC Trial
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a randomized controlled trial that aims to evaluate the efficacy of multisensory stimulation in patients with acute stroke who have disorders of consciousness (DOC). Participants will be randomly allocated to a rehabilitation group or a rehabilitation with multisensory stimulation group., and changes in the Coma Recovery Scale-Revised (CRS-R) score will be compared between the two groups as the primary outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In addition to standard rehabilitation, multisensory stimulation (visual, auditory, olfactory, gustatory, tactile, kinesthetic, proprioceptive, and somatosensory) will be administered for 15 minutes per session. On the day informed consent is obtained, the intervention will be conducted in the afternoon; from the following day onward, it will be provided twice daily (morning and afternoon), five days per week.
Interventions/Control_2
Standard rehabilitation will be administered.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Yeonghee |
| Middle name | |
| Last name | Lee |
Organization
Nagasaki University Hospital
Division name
Rehabilitation Department
Zip code
8528102
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki
TEL
0958197258
yeong-lee@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yeonghee |
| Middle name | |
| Last name | Lee |
Organization
Nagasaki University Hospital
Division name
Rehabilitation Department
Zip code
8528501
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki
TEL
0958197258
Homepage URL
yeong-lee@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Yeonghee Lee
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki
Tel
0958197258
yeong-lee@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2028 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069454
