Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Transcranial Magnetic Stimulation to Improve Speech in Aphasia

This study has been completed.
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Harvard Medical School
University of Pennsylvania
Information provided by (Responsible Party):
Margaret Naeser, Boston University
ClinicalTrials.gov Identifier:
NCT00608582
First received: January 24, 2008
Last updated: December 1, 2016
Last verified: December 2016
  Purpose

The purpose of this study is to examine whether repetitive transcranial magnetic stimulation (rTMS) can be used to improve speech in chronic stroke patients with aphasia. Aphasia patients can have problems with speech production. The rTMS procedure allows painless, noninvasive stimulation of human cortex from outside the head.

Chronic aphasia patients have been observed in our functional magnetic resonance brain imaging studies to have excess brain activation in brain areas possibly related to language on the right side of the brain (opposite side to where the stroke took place). It is expected that suppression of activity in the directly targeted brain region will have an overall modulating effect on the neural network for naming (and propositional speech) and will result in behavioral improvement.


Condition Intervention Phase
Aphasia
Cerebrovascular Stroke
Device: Transcranial Magnetic Stimulation, Repetitive
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation to Improve Speech

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Picture Naming [ Time Frame: Baseline and 2 months after the last rTMS treatment session ]
    Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures

  • Phrase Length [ Time Frame: Baseline and 2 months after the last rTMS treatment session ]
    Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description


Enrollment: 63
Study Start Date: July 2002
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real rTMS
These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS), treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Device: Transcranial Magnetic Stimulation, Repetitive
10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
Sham Comparator: Sham rTMS
Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS treatments are identical to the Real rTMS treatments, however, no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.
Device: Transcranial Magnetic Stimulation, Repetitive
10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.

Detailed Description:

OBJECTIVE: The purpose of this research is to investigate whether repetitive transcranial magnetic stimulation (rTMS) can improve speech in chronic stroke patients with aphasia. TMS allows painless, noninvasive stimulation of brain cortex (1 cm x 1 cm). Slow (1 Hz) rTMS appears to decrease excitability in the targeted cortical region of interest (ROI) leading to measurable behavioral effects. Chronic aphasia patients have been observed in our fMRI work (and others) to have increased activation in right (R) Broca's and other R language homologues during language tasks. It is hypothesized that suppression of activity in a directly targeted right hemisphere (RH) ROI will have an overall modulating effect on functionally connected elements of the distributed neural network for naming (and propositional speech), and will result in behavioral improvement.

RESEARCH PLAN AND METHODS:

Nonfluent aphasia patients (>6 Mo. poststroke) will be studied. The rTMS treatments in Boston take place at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School under the supervision of Alvaro Pascual-Leone, M.D., Ph.D. and additional patients will be studied at the Hospital of the University of Pennsylvania, H. Branch Coslett, M.D., who is a P.I. on that subcontract. This is a blinded, randomized, sham-control, incomplete crossover design. Naming and language tests are obtained pre- and post- rTMS.

Treatment Design: Multiple Baseline Language Evaluations (x3) are performed at Entry (Boston Naming Test, BNT; and Boston Diagnostic Aphasia Exam, BDAE). Primary Outcome Measures are BNT; and Number of Words per Longest Phrase Length (cookie theft picture description) from the BDAE. Patients are randomly assigned to receive a series of either Sham rTMS followed by a series of Real rTMS; OR they receive only the series of Real rTMS. The Sham series is identical to the Real, however, no magnetic pulse is emitted from the coil, although the patient hears the same clicking sound emitted from the coil. Due to space limitation here, only the Real rTMS treatment schedule is described.

There are two rTMS Phases: During Phase 1, the single, best RH cortical ROI to suppress with rTMS to improve picture naming, is determined for each patient. Real rTMS (1 Hz, 90% motor threshold) is applied for 10 minutes, in separate rTMS sessions, to each of 4 different RH cortical ROIs (R ant. BA 45; R post. BA 45; R BA 44 and R M1, mouth). Snodgrass & Vanderwart (S&V, 1980) Picture Naming is tested immediately before and after each ROI has been suppressed with rTMS. The single RH ROI which is associated with at least a 2 SD improvement (above S&V Naming, tested 3x at Baseline), immediately following 10 minutes of rTMS to suppress that cortical area, is considered to be the Best Response ROI for that patient. During Phase 2, the Best Response ROI from Phase 1 is suppressed for 20 minutes, 5 days per week, 2 weeks. All patients receive follow-up BNT and BDAE testing at 2 months following the 10th Real (or Sham) rTMS treatment.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Right Handed
  • Single, Left Hemisphere Cerebrovascular Stroke
  • Must be at least 6 months poststroke onset
  • Native Speaker of English
  • Clinical Diagnosis of Aphasia

Exclusion Criteria:

  • Intracranial metallic body from prior neurosurgical procedure
  • Implanted metallic devices: pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt
  • Past history of seizure within 1 year
  • Pregnancy
  • History of substance abuse within last 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608582

Locations
United States, Massachusetts
VA Boston Healthcare System, Jamaica Plain Campus, Boston University Aphasia Research Center (12-A), 150 So. Huntington Ave.
Boston, Massachusetts, United States, 02130
Berenson-Allen Center for Noninvasive Brain Stimulation, 330 Brookline Ave, Kirstein Bldg., Dept. of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
Department of Neurology, Hospital of the University of Pennsylvania, 3 W. Gates Bldg.
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Boston University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Harvard Medical School
University of Pennsylvania
Investigators
Study Chair: Margaret A Naeser, Ph.D. Department of Neurology, Boston University School of Medicine, Boston, MA
Principal Investigator: H B Coslett, M.D. Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA
Principal Investigator: Alvaro Pascual-Leone, M.D., Ph.D. Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
  More Information

Additional Information:
Publications:
Naeser MA, Martin PI, Ho M, Treglia E, Kaplan E, Baker EH, and Pascual-Leone A. Transcranial Magnetic Stimulation and Aphasia Research. Book Chapter, Advances in the Neural Substrates of Language: Toward a Synthesis of Basic Science and Clinical Research. Vol 2: Language Processing in the Brain: Special Populations. Miriam Faust (Ed.), Malden, MA: Wiley-Blackwell, 2012.

Responsible Party: Margaret Naeser, Research Professor of Neurology, Boston University
ClinicalTrials.gov Identifier: NCT00608582     History of Changes
Other Study ID Numbers: NIH-DC05672
R01DC005672 ( US NIH Grant/Contract Award Number )
Boston Medical Ctr IRB-H22484 ( Other Identifier: Boston University School of Medicine )
VA Boston Healthcare IRB-1145 ( Other Identifier: VA Boston Healthcare System )
Study First Received: January 24, 2008
Results First Received: September 22, 2016
Last Updated: December 1, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Boston University:
Transcranial Magnetic Stimulation, Repetitive
TMS
Treat Naming
Aphasia
Chronic Stroke
Randomized, Controlled Trial

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

ClinicalTrials.gov processed this record on April 21, 2017