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Effects of rTMS Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia

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ClinicalTrials.gov Identifier: NCT02556385
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Device: High frequency rTMS Device: Low frequency rTMS Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2015
Actual Primary Completion Date : August 24, 2017
Actual Study Completion Date : August 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: High frequency rTMS
Most activated area from fNIRS with language task: Perileisional Broca's area
Device: High frequency rTMS
Most activated area from fNIRS findings: Perileisional Broca's area, 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

Active Comparator: Low Frequency rTMS
Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
Device: Low frequency rTMS
Most activated area from fNIRS findings: Contralesional homologs of Broca's area, 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




Primary Outcome Measures :
  1. BNT (Boston naming test) [ Time Frame: 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) ]
    speech evaluation tool for measuring the confrontational word retrieval function


Secondary Outcome Measures :
  1. WAB (Western aphasia battery) [ Time Frame: 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) ]
    speech evaluation tool for screening the presence, degree, and type of aphaisa

  2. Laterality index (LI) [ Time Frame: 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) ]
    From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemisphereic Hbo values, respectively)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556385


Locations
Korea, Republic of
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

Responsible Party: Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02556385     History of Changes
Other Study ID Numbers: B-1507-308-006
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Stroke
Aphasia
Aphasia, Broca
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms