UMIN-ICDS Clinical Trial

Public title

A study of neuropathic pain characteristics using electroencephalography and transcranial magnetic stimulation

Acronym

MultiEP-NP Study

Scientific Title

Characterizing the pathophysiology of neuropathic pain using multimodal electrophysiological data: a cross-sectional observational study

Scientific Title:Acronym

MultiEP-NP Study

Region

Japan

Condition

Spinal cord injury, stroke, limb amputation, and brachial plexus injury; healthy adults as controls

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Neuropathic pain is thought to arise from a combination of impaired somatosensory input due to lesions of the somatosensory pathways and deafferentation, altered motor output including changes in corticospinal excitability, and abnormal resting-state brain networks. However, few studies have assessed these aspects simultaneously in the same individuals. The purpose of this study is to perform multimodal electrophysiological assessments (multichannel somatosensory evoked potentials (SEPs) and contact heat evoked potentials (CHEPs), corticospinal excitability and motor cortex mapping using transcranial magnetic stimulation (TMS), and network analysis of resting-state electroencephalography) in individuals with upper limb amputation, brachial plexus injury, spinal cord injury, or stroke, as well as in healthy adults, and to clarify how these measures correspond to the clinical features of neuropathic pain (evoked pain, musculoskeletal pain, and spontaneous pain). The findings will provide a basis for electrophysiologically informed selection of rehabilitation strategies according to symptom profiles.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Network metrics derived from source-space connectivity of resting-state electroencephalography (64 channels; 5 minutes each with eyes closed and eyes open), including hub measures such as nodal degree and betweenness centrality. Assessment is performed at a single time point (one session), and the metrics are analyzed in relation to spontaneous pain intensity (Numerical Rating Scale).

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Individuals aged 18 years or older who meet any of the following: (1) upper limb amputation, (2) brachial plexus injury, (3) spinal cord injury, (4) stroke, or (5) healthy adults as a control group. All participants must be able to understand the explanation of the study and to provide written informed consent of their own free will.

Key exclusion criteria

(1) Individuals unable to provide voluntary consent; (2) individuals for whom written informed consent cannot be obtained; (3) individuals with a history of epilepsy or judged to be at high risk of seizures (contraindication to transcranial magnetic stimulation); (4) individuals with intracranial metal, a cardiac pacemaker, a cochlear implant, or other implanted devices (contraindication to transcranial magnetic stimulation); (5) women who are pregnant or may be pregnant; (6) individuals with skin lesions or wounds at the stimulation sites; (7) individuals judged unsuitable for participation by the principal investigator.

Target sample size

130

Name of lead principal investigator

1st name	Osumi
Middle name
Last name	Michihiro

Organization

Kio university

Division name

Neurorehabilitation Research Center, Kio University

Zip code

635-0832

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan

TEL

0745541601

Email

m.ohsumi@kio.ac.jp

Name of contact person

1st name	Osumi
Middle name
Last name	Michihiro

Organization

Kio university

Division name

Neurorehabilitation research center

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun

TEL

0745541601

Homepage URL

Email

m.ohsumi@kio.ac.jp

Institute

Kio university

Institute

Department

Personal name

Organization

Kio university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kio university

Address

4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan

Tel

0745541601

Email

m.ohsumi@kio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2031

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center, cross-sectional observational study without any therapeutic intervention. A total of 130 participants will be enrolled: 20 individuals with upper limb amputation, 20 with brachial plexus injury, 20 with spinal cord injury, 20 with stroke, and 50 healthy adults. Each participant undergoes a single measurement session comprising (1) multichannel somatosensory evoked potentials and contact heat evoked potentials, (2) corticospinal excitability assessed by transcranial magnetic stimulation (motor evoked potential amplitude, short-interval intracortical inhibition, and intracortical facilitation) together with motor cortex mapping, and (3) resting-state electroencephalography recorded for 5 minutes each with eyes open and eyes closed. After preprocessing, source reconstruction is performed on the resting-state data, source-space connectivity is computed, and graph-theoretical network analysis is applied. Associations between these electrophysiological measures and clinical findings, including pain intensity (Numerical Rating Scale) and neuropathic pain screening scores, are examined using between-group comparisons, correlation analysis, regression analysis, and cluster analysis. Resting-state electroencephalography data from approximately 50 healthy adults acquired in a previous study will also be used secondarily, and batch effects arising from differences in recording period and equipment will be adjusted using statistical harmonization methods such as ComBat. The study is conducted after approval by the Research Ethics Committee of Kio University, and written informed consent is obtained from all participants.

Registered date

2026

Year

09

Month

01

Day

Last modified on

2026

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071863