Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390192
• Other study ID #: 2013-06-002-009
• Status: Completed
• Phase: N/A
• Start date: January 13, 2015
• Est. completion date: March 13, 2018

Study information

• Verified date: December 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Dual-mode stimulation
1Hz rTMS over contralesional primary motor cortex and anodal tDCS over ipsilesional primary motor cortex are simultaneously simulated.
• Single sham stimulation
1Hz rTMS over contralesional primary motor cortex and sham tDCS (no stimulation) over ipsilesional primary motor cortex are simultaneously simulated.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment score	Fugl-Meyer Assessment score reflects a motor impairment of a patient. Score range is between 0 and 100.	2 months post-stimulation