UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046520 |
|---|---|
| Receipt number | R000053077 |
| Scientific Title | Cortical reorganization underlying motor recovery after low-frequency repetitive transcranial magnetic stimulation combined with occupational therapy in chronic stroke |
| Date of disclosure of the study information | 2022/01/02 |
| Last modified on | 2023/02/12 11:48:16 |
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Basic information
Public title
Cortical reorganization underlying motor recovery after low-frequency repetitive transcranial magnetic stimulation combined with occupational therapy in chronic stroke
Acronym
Cortical reorganization underlying motor recovery after low-frequency repetitive transcranial magnetic stimulation combined with occupational therapy in chronic stroke
Scientific Title
Cortical reorganization underlying motor recovery after low-frequency repetitive transcranial magnetic stimulation combined with occupational therapy in chronic stroke
Scientific Title:Acronym
Cortical reorganization underlying motor recovery after low-frequency repetitive transcranial magnetic stimulation combined with occupational therapy in chronic stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neural mechanisms underlying motor recovery after low-frequency repetitive transcranial magnetic stimulation combined with occupational therapy in chronic stroke patients using functional magnetic resonance imaging (fMRI).
Basic objectives2
Others
Basic objectives -Others
To characterize cortical activation changes after low-frequency repetitive transcranial magnetic stimulation combined with occupational therapy and their relationship to the degree of motor recovery using fMRI.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in neural activation patterns assessed with fMRI before and after therapy
Key secondary outcomes
Fugl-Meyer Assessment
Wolf Motor Function Test
Action Research Arm Test
Motor Activity Log
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During the 14-day hospitalization period, each patient received 18 treatment sessions consisting of 20-min low-frequency repetitive transcranial magnetic stimulation and 120-min intensive occupational therapy.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) age at the time of intervention of 18-80 years.
2) time after stroke onset of greater than 12 months.
3) mild-to-moderate upper limb hemiparesis (Action Research Arm Test score >= 16).
4) a plateau in maximum motor recovery after conventional rehabilitation.
5) a history of single subcortical stroke only.
Key exclusion criteria
1) cognitive deficits (Mini-Mental State Examination score <= 23).
2) active systemic or mental illness requiring medical management.
3) seizure.
4) pathological conditions known to be contraindications for rTMS in the guidelines suggested by Wassermann (1998).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Katai |
Organization
Kakeyu Hospital
Division name
Department of Neurology
Zip code
386-0396
Address
1308 Kakeyuonsen, Ueda, Nagano, Japan
TEL
0268-44-2111
skatai@kakeyu-hp.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Katai |
Organization
Kakeyu Hospital
Division name
Department of Neurology
Zip code
386-0396
Address
1308 Kakeyuonsen, Ueda, Nagano, Japan
TEL
0268-44-2111
Homepage URL
skatai@kakeyu-hp.com
Sponsor or person
Institute
Kakeyu Hospital
Institute
Department
Personal name
Funding Source
Organization
Kakeyu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kakeyu Hospital
Address
1308 Kakeyuonsen, Ueda, Nagano, 386-0396 Japan
Tel
0268-44-2111
skatai@kakeyu-hp.com
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
鹿教湯病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 02 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.ynirp.2023.100156
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.ynirp.2023.100156
Number of participants that the trial has enrolled
30
Results
After the treatment, the motor function test scores of FMA and WMFT improved significantly. The LI during movements of the affected hand increased significantly, suggesting changes in the activation balance within the primary motor, primary lesioned hemisphere. Moreover, the LI changes in the aforementioned areas significantly correlated with gains in the WMFT.
Results date posted
| 2023 | Year | 02 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Fugl-Meyer Assessment (FMA), Wolf Motor Function Test (WMFT), Action Research Arm Test (ARAT), functional magnetic resonance imaging (fMRI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 18 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 18 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053077
