UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054364 |
|---|---|
| Receipt number | R000062097 |
| Scientific Title | Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial - |
| Date of disclosure of the study information | 2024/05/25 |
| Last modified on | 2024/12/19 10:43:38 |
* 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
Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial -
Acronym
Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial -
Scientific Title
Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial -
Scientific Title:Acronym
Efficacy of brain-machine interface training combined with botulinum toxin for severe hand paralysis after stroke - A single-blind randomized controlled trial -
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether an intervention combining Brain-Machine Interface training and botulinum toxin can improve finger function and reduction spasticity in patients with severe hand paralysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Fugl-Meyer Assessment(FMA) hand scale, Modified Ashworth Scale(MAS) of Hand flexor muscle
Key secondary outcomes
FMA upper limb score/sensory score for upper limb, Action Research Arm Test(ARAT), Motor Activity Log(MAL), Disability Assessment Scale(DAS), Visual Analogue Scale(VAS) for pain, Stroke Impact Scale(SIS)hand scale, Electroencephalography, surface electromyography, and evoked electromyography at rest and during attempts at finger extension
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions (BMI group): Botulinum toxin plus BMI training.
In BMI group, patients are provided with training using electroencephalogram-induced orthoses and electrical stimulators.
Daily training dose: conventional occupational therapy for 40 minutes and BMI training for 40 minutes.
Intervention period: 6 days
Interventions/Control_2
Control (Sham stimulation group): Botulinum toxin plus Sham stimulation.
In the Sham stimulation group, patients are provided with training using electric orthoses and electrical stimulators that operate independently of EEG.
Daily training dose: conventional occupational therapy for 40 minutes and Sham training for 40 minutes.
Intervention period: 6 days
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) age between 20 to 80 years
2) time since stroke onset longer than 180 days
3) inability to extend the paretic finger after first stroke (Stroke Impairment Assessment Set (SIAS) < IB)
4) Modified Ashworth Scale (MAS) of Hand flexor muscle >= 1+
5) Patients who are hospitalized after botulinum toxin to the hand flexor muscle
Key exclusion criteria
A patient who falls under the following;
1) subarachnoid hemorrhage
2) recurrent stroke
3) other neuromuscular disorders
4) severe spasticity or contracture of the fingers and are unable to extend or close the fingers passively (MAS >= 3)
5) phenomenon of forced grasp, apraxia, and unilateral spatial neglect
6) sever mental disorder (affects concentration and continuation of training)
7) cognitive deficits as determined by Mini mental state examination <= 23
8) significant hearing or visual impairment
9) Unable to attach the myoelectric electrode due to skin disease or difficult to wear the hand electric orthosis
10) serious hepatic, renal, cardiovascular, or respiratory disorders
11) Uncured malignancy
12) no history of seizures within the past 2 years
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Anmoto |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
ot-dep@nagoya-rehab.or.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Anmoto |
Organization
Nagoya City Rehabilitation Agency
Division name
Division of Occupational Therapy
Zip code
467-8622
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL
052-835-3811
Homepage URL
ot-dep@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
Funding Source
Organization
Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
LIFESCAPES Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City Rehabilitation Agency
Address
1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel
052-835-3811
soumubu@nagoya-u.or.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
名古屋市総合リハビリテーション事業団（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2024 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062097
