UMIN-CTR Clinical Trial

Basic information
Public title	Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Acronym	Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Scientific Title	Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Scientific Title:Acronym	Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to verify the effects of concurrent peripheral nerve stimulation (PNS) therapy on the forearm of the paralyzed side of the body, upper limb function, and improved movement in daily living of the stroke patients with upper limb paralysis underdoing repetitive transcranial magnetic stimulation (r-TMS) therapy and 2-week intensive occupation therapy (OT).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wolf motor function test
Key secondary outcomes	Fugl-Meyer Assessment 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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Apply one hour per day of PNS therapy to the forearm of the paralyzed side of the body during OT to stroke patients with upper limb paralysis who are undergoing r-TMS therapy and 2-week intensive OT.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Aged 20 years or older at the time consent was obtained. Ability to voluntarily extend at least three fingers, including the thumb. Ability to raise the arm on the affected side to the level of the nipple or higher. Six months or more have passed since the onset of stroke. PNS therapy has been prescribed by the patient's physician. Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria	Severe aphasia, agnosia, apraxia, or other severe higher brain dysfunction that interferes with the procedures of the study. Cutaneous anesthesia. Having an inflammatory disease with arthritic inflammation, such as rheumatoid arthritis. Previous participation in this study. Previous history of receiving concurrent PNS therapy with r-TMS therapy. Patients who have otherwise been determined to be ineligible as a subject by the principal investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Mutai
Organization	Shinshu University
Division name	Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code	390-8621
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2405
Email	hitmutai@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Mutai
Organization	Shinshu University
Division name	Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code	390-8621
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL	0263-37-2405
Homepage URL
Email	hitmutai@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Shinshu University
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	Shinshu University Independent Ethics Committee
Address	3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel	0263-37-2572
Email	mdrinri@shinshu-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	鹿教湯病院（長野県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 22 Day

Related information
URL releasing protocol	https://journals.sagepub.com/doi/full/10.1177/1569186120901633
Publication of results	Published

Result
URL related to results and publications	https://journals.sagepub.com/doi/full/10.1177/1569186120901633
Number of participants that the trial has enrolled	11
Results	The Wolf Motor Function Test, Fugl-Meyer Assessment, and Motor Activity Log showed significant improvement after intervention in the peripheral nerve stimulation group. In particular, hand scores on the Fugl-Meyer Assessment improved significantly in the peripheral nerve stimulation group compared to controls (median change: 2 vs. 0; p = 0.021, r = 0.49).
Results date posted	2020 Year 12 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The subjects were chronic stroke patients who participated in a two-week inpatient programme including repetitive transcranial magnetic stimulation and occupational therapy.
Participant flow	the peripheral nerve stimulation group (11 patients who underwent peripheral nerve stimulation)
Adverse events	Nothing
Outcome measures	Wolf motor function test, Fugl-Meyer Assessment, Motor Activity Log
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 07 Day
Date of IRB	2017 Year 11 Month 13 Day
Anticipated trial start date	2017 Year 11 Month 22 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 28 Day
Date trial data considered complete	2019 Year 03 Month 28 Day
Date analysis concluded	2019 Year 10 Month 13 Day

Other
Other related information

Management information
Registered date	2017 Year 11 Month 22 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034343