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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

January 24, 2008
December 1, 2016
July 2002
June 2013   (Final data collection date for primary outcome measure)
  • 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
Number of pictures named on the Boston Naming Test, and naming subtests of the Boston Diagnostic Aphasia Exam [ Time Frame: 2 months and 6 months after the completion of a series of TMS treatments ]
Complete list of historical versions of study NCT00608582 on ClinicalTrials.gov Archive Site
Not Provided
Number of words per longest phrase length, propositional speech, BDAE [ Time Frame: 2 months and 6 months after completion of a series of TMS treatments ]
Not Provided
Not Provided
 
Transcranial Magnetic Stimulation to Improve Speech in Aphasia
Transcranial Magnetic Stimulation to Improve Speech

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • Aphasia
  • Cerebrovascular Stroke
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.
  • 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.
    Intervention: Device: Transcranial Magnetic Stimulation, Repetitive
  • 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.
    Intervention: Device: Transcranial Magnetic Stimulation, Repetitive

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00608582
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 )
No
Not Provided
No
Not Provided
Margaret Naeser, Boston University
Boston University
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Harvard Medical School
  • University of Pennsylvania
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
Boston University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP