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Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Stroke

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ClinicalTrials.gov Identifier: NCT03390192
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 13, 2015
Actual Primary Completion Date : March 13, 2018
Actual Study Completion Date : March 13, 2018

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.




Primary Outcome Measures :
  1. Fugl-Meyer Assessment score [ Time Frame: 2 months post-stimulation ]
    Fugl-Meyer Assessment score reflects a motor impairment of a patient. Score range is between 0 and 100.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390192


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03390192     History of Changes
Other Study ID Numbers: 2013-06-002-009
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
Noninvasive brain stimulation
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases