Clinical trial NCT02591719: Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia
Official title: Effects of Repetitive Transcranial Magnetic Stimulation Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Aphasia
Keywords: Functional Near-Infrared Spectroscopy
Stroke
Aphasia
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: BNT (Boston Naming Test)
timeFrame: up to 2 weeks
Secondary outcomes:
measure: WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)
timeFrame: up to 6 weeks
measure: 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)
timeFrame: up to 6 weeks
measure: BNT (Boston Naming Test)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
state: Korea, Gyeonggi-do
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
name: Nam-Jong Paik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: