NCT02556385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2017

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

September 13, 2015

Last Update Submit

August 29, 2022

Conditions

StrokeAphasia

Outcome Measures

Primary Outcomes (1)

  • BNT (Boston naming test)

    speech evaluation tool for measuring the confrontational word retrieval function

    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 (2)

  • WAB (Western aphasia battery)

    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)

  • Laterality index (LI)

    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)

Study Arms (2)

High frequency rTMS

EXPERIMENTAL

Most activated area from fNIRS with language task: Perileisional Broca's area

Device: High frequency rTMS

Low Frequency rTMS

ACTIVE COMPARATOR

Most activated area from fNIRS with language task: Contralesional homologs of Broca's area

Device: Low frequency rTMS

Interventions

High frequency rTMSDEVICE

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

High frequency rTMS
Low frequency rTMSDEVICE

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

Low Frequency rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

StrokeAphasia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nam-Jong Paik, MD, PhD

    Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 22, 2015

Study Start

October 1, 2015

Primary Completion

August 24, 2017

Study Completion

August 24, 2017

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

KR(1)