Clinical trial NCT02556385: Effects of rTMS Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia
Official title: Effects of Repetitive Transcranial Magnetic Stimulation Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aphasia
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the safety and clinical efficacy of high or low-frequency repetitive transcranial magnetic stimulation based on brain activation with functional near infrared spectroscopy in poststroke nonfluent aphasia patients.

Detailed description: In poststsroke aphasia rehabilitation, repetitive transcranial stimulation (rTMS) studies aimed to reinforce the activity of the brain regions in the left hemisphere. This goal can be achieved by using an excitatory protocol to reactivate the perilesional area or inhibitory protocol to reduce activities in the contralesional area. However, most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.

In the present pilot study, investigators will perform functional near-infrared spectroscopy (fNIRS) prior to rTMS treatment for selection of the most appropriate application of stimulation. Stimulation site and protocol (high frequency or low frequency rTMS) will be determined by activation pattern from the fNIRS findings with language task in individual patients.

Eligibility criteria: Inclusion Criteria:

* 18-80 yrs old
* Right-handed
* Radiologically confirmed left hemisphere stroke
* Fluent in Korean
* First ever stroke
* More than 1 year from stroke onset
* 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: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy)
Secondary outcomes:
measure: WAB (Western aphasia battery)
timeFrame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy)
measure: Laterality index (LI)
timeFrame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy)
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: Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
name: Nam-Jong Paik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: