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

NCT03647319 | Completed

• 1 other identifier: 2013-06-002-016
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-stroke Cognitive Impairment

Keywords

Noninvasive Brain Stimulation; Repetitive Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Accuracy of 2-back verbal working memory task

  Accuracy (percentile) of 2-back verbal working memory task

  Change from Pre-intervention at 2 months

Study Arms (3)

Anodal Dual-mode stimulation

EXPERIMENTAL

10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of anodal tDCS on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.

Device: High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC

Cathodal Dual-mode stimulation

EXPERIMENTAL

10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of cathodal tDCS on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.

Device: High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC

Single sham stimulation

ACTIVE COMPARATOR

10Hz of rTMS was applied over the left DLPFC for 10 minutes with simultaneous application of tDCS with sham mode (no stimulation) on the right DLPFC. Each participant's 2-back verbal/nonverbal working memory task and variety cognitive function test are assessed and their resting-state fMRI data at three times: prior to stimulation (pre-stimulation), immediately after stimulation (post-stimulation) and 2 months after stimulation (f/u) are acquired.

Device: High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC

Interventions

High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC DEVICE

10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.

Anodal Dual-mode stimulation

High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC DEVICE

10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.

Cathodal Dual-mode stimulation

High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC DEVICE

10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.

Single sham stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever stroke patients
• Subacute stage (less than 4 weeks)
• Who can perform the 2-back verbal and non-verbal working memory task

You may not qualify if:

• K-MMSE score under 9
• Major active neurological disease or psychiatric disease
• A history of seizure
• Metallic implants in their brain

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: August 27, 2018
• Study Start: April 11, 2013
• Primary Completion: November 10, 2016
• Study Completion: November 10, 2016
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

KR (1)