Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Stroke

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03390192

Collaborator

(none)

Enrollment

Location

Arms

37.9

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both inhibitory rTMS (1Hz) and anodal tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Dual-mode stimulation Device: Single sham stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study

Actual Study Start Date :

Jan 13, 2015

Actual Primary Completion Date :

Mar 13, 2018

Actual Study Completion Date :

Mar 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual-mode stimulation Dual-mode stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and active tDCS. 1 Hz of rTMS is applied over the contralesional M1 for 20 minutes with simultaneous application of anodal tDCS on the ipsilesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.	Device: Dual-mode stimulation 1Hz rTMS over contralesional primary motor cortex and anodal tDCS over ipsilesional primary motor cortex are simultaneously simulated.
Active Comparator: Single sham stimulation Single sham stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and sham tDCS. 1 Hz of rTMS over the contralesional M1 was applied for 20 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the ipsilesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.	Device: Single sham stimulation 1Hz rTMS over contralesional primary motor cortex and sham tDCS (no stimulation) over ipsilesional primary motor cortex are simultaneously simulated.

Arm

Intervention/Treatment

Experimental: Dual-mode stimulation

Dual-mode stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and active tDCS. 1 Hz of rTMS is applied over the contralesional M1 for 20 minutes with simultaneous application of anodal tDCS on the ipsilesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.

Device: Dual-mode stimulation

1Hz rTMS over contralesional primary motor cortex and anodal tDCS over ipsilesional primary motor cortex are simultaneously simulated.

Active Comparator: Single sham stimulation

Single sham stimulation is applied over the bilateral primary motor cortex (M1) using active rTMS and sham tDCS. 1 Hz of rTMS over the contralesional M1 was applied for 20 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the ipsilesional M1. Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.

Device: Single sham stimulation

1Hz rTMS over contralesional primary motor cortex and sham tDCS (no stimulation) over ipsilesional primary motor cortex are simultaneously simulated.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Assessment score [2 months post-stimulation]
Fugl-Meyer Assessment score reflects a motor impairment of a patient. Score range is between 0 and 100.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First-ever stroke patients
Subacute stage (less than 4 weeks)
Total Fugl-Meyer Assessment (FMA) score under 84

Exclusion Criteria:

Major active neurological disease or psychiatric disease
A history of seizure
Metallic implants in their brain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT03390192

Other Study ID Numbers:

2013-06-002-009

First Posted:

Jan 4, 2018

Last Update Posted:

Sep 19, 2019

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Samsung Medical Center

Noninvasive brain stimulation

Repetitive Transcranial Magnetic Stimulation

Transcranial Direct Current Stimulation

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Sep 19, 2019