Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Post-stroke Cognitive Impairment

Post-stroke Cognitive Impairment 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: NCT03647319
• Other study ID #: 2013-06-002-016
• Status: Completed
• Phase: N/A
• Start date: April 11, 2013
• Est. completion date: November 10, 2016

Study information

• Verified date: September 2019
• 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 post-stroke cognitive impairment patients' cognitive 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 facilitatory rTMS (10Hz) and anodal or cathodal tDCS (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (DLPFCs) was investigated to compare its modulatory effects with single facilitatory rTMS stimulation in post-stroke cognitive impairment patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 10, 2016
• Est. primary completion date: November 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First-ever stroke patients

• Subacute stage (less than 4 weeks)

• Who can perform the 2-back verbal and non-verbal working memory task

Exclusion Criteria:

• K-MMSE score under 9

• Major active neurological disease or psychiatric disease

• A history of seizure

• Metallic implants in their brain

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Post-stroke Cognitive Impairment
• Stroke

Intervention

Device:
• High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC
10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.
• High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC
10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.
• High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC
10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.

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	Accuracy of 2-back verbal working memory task	Accuracy (percentile) of 2-back verbal working memory task	Change from Pre-intervention at 2 months