Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia

Stroke Clinical Trial

Official title:

Effects of Repetitive Transcranial Magnetic Stimulation Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02591719
• Other study ID #: B-1507-308-006/P2
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Seoul National University Bundang Hospital
• Contact: Nam-Jong Paik, MD, PhD
• Phone: 82-031-787-7731
• Email: njpaik[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the safety and clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.

Description:

Most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.

In the present randomized controlled trial, investigators will perform fNIRS prior to rTMS treatment to select the stimulation method. Stimulation site (perilesional or contralesional) and frequency (excitatory high or inhibitory low) will be determined by activation pattern from the fNIRS with language task in individual patients.

The patient who shows a dominant neural activity at perilesional Broca's area on fNIRS scanning will be randomly allocated into two groups: high frequency stimulation group and sham stimulation group. If a patient shows a dominant neural activity at contralesional homologs of Broca's area on fNIRS scanning, the patient will be allocated to a low frequency stimulation group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 yrs old

• Right-handed

• Radiologically confirmed left hemisphere stroke within 6 months

• Fluent in Korean

• First ever stroke

• Non-fluent (motor-dominant) aphasia

• Written informed consent

Exclusion Criteria:

• Previous medical histories of stroke, cerebral vascular operation,

• Seizure

• Patients with traumatic brain injury

• Unable to perform the language task

• Severe cognitive impairment (MMSE less than 16)

• Skin lesion in the stimulation site of scalp

• Metal implants in the body (cardiac pacemaker or aneurysm clip)

• Pregnancy, breastfeeding

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• MagPro magnetic stimulator (HF rTMS)
Most activated area from fNIRS findings: Perilesional Broca's area. Use the true coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
• MagPro magnetic stimulator (sham)
Most activated area from fNIRS findings: Perilesional Broca's area. Use the sham coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
• MagPro magnetic stimulator (LF rTMS)
Most activated area from fNIRS findings: Contralesional homologs of Broca's area. Use the true coil. Low frequency rTMS (1Hz), Number of total stimuli: 1200, Location: Contralesional homologs of Broca's area (Pars triangularis), Intensity: 90% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital	Seongnam-si	Korea, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BNT (Boston Naming Test)	speech evaluation tool for measuring the confrontational word retrieval function	up to 2 weeks
Secondary	WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)	Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'	up to 6 weeks
Secondary	LI (Laterality Index; From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemispheric HbO (oxyhemoglobin) or total Hb values, respectively)	Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'	up to 6 weeks
Secondary	BNT (Boston Naming Test)	speech evaluation tool for measuring the confrontational word retrieval function	4 weeks