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

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ClinicalTrials.gov Identifier: NCT02591719
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : July 17, 2019
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 repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Device: MagPro magnetic stimulator (HF rTMS) Device: MagPro magnetic stimulator (sham) Device: MagPro magnetic stimulator (LF rTMS) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Repetitive Transcranial Magnetic Stimulation Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia: Randomized Controlled Trial
Study Start Date : November 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: MagPro magnetic stimulator (HF rTMS)
Most activated area from fNIRS with language task: Perilesional Broca's area
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
Other Name: High frequency rTMS

Sham Comparator: MagPro magnetic stimulator (sham)
Most activated area from fNIRS with language task: Perilesional Broca's area
Device: 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
Other Name: Sham stimulation

Active Comparator: MagPro magnetic stimulator (LF rTMS)
Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
Device: 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

Other Name: low frequency rTMS




Primary Outcome Measures :
  1. BNT (Boston Naming Test) [ Time Frame: up to 2 weeks ]
    speech evaluation tool for measuring the confrontational word retrieval function


Secondary Outcome Measures :
  1. WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia) [ Time Frame: up to 6 weeks ]
    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'

  2. 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) [ Time Frame: up to 6 weeks ]
    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'

  3. BNT (Boston Naming Test) [ Time Frame: 4 weeks ]
    speech evaluation tool for measuring the confrontational word retrieval function



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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 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

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): NCT02591719


Contacts
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Contact: Nam-Jong Paik, MD, PhD 82-031-787-7731 njpaik@snu.ac.kr
Contact: Ji-Young Lee, MD 82-031-787-6883 bluebelll@naver.com

Locations
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Korea, Republic of
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Nam-Jong Paik, MD, PhD    82-031-787-7731    njpaik@snu.ac.kr   
Contact: Ji-Hong Park, MD       parkjihong.md@gmail.com   
Principal Investigator: Nam-jong Paik, MD, PhD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Nam-Jong Paik, MD, PhD Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

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Responsible Party: Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02591719     History of Changes
Other Study ID Numbers: B-1507-308-006/P2
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms