Transcranial Magnetic Stimulation to Improve Speech in Aphasia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Harvard University
University of Pennsylvania
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00608582
First received: January 24, 2008
Last updated: January 9, 2013
Last verified: January 2013

January 24, 2008
January 9, 2013
July 2002
March 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00608582 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
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. Patients are studied with overt naming fMRI brain scan pre-and post-rTMS at the Boston University Center for Biomedical Imaging.

RESEARCH PLAN AND METHODS:

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. We plan to study 20 nonfluent aphasia patients (>6 Mo. poststroke). An additional 20 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 (and overt naming fMRI scans) are obtained pre- and post- rTMS. All fMRI scans are covered under the PI's VA Merit Review Grant.

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 Naming subtests and Spontaneous Speech (cookie theft picture description) from the BDAE. Naming ability for Snodgrass & Vanderwart (S&V, 1980) pictures is also tested at Baseline. 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). S&V 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 Baseline S&V Naming), immediately following 10 minutes of rTMS to suppress that cortical area, is considered to be the Best Response ROI for that patient. We have observed that suppression of R post. BA 45 to be the Best Response area in 9 previous aphasia cases. 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 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 rTMS treatments, only. There is pre-testing, and post-testing at 2 months and 6 months after the last Real 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.
 
Active, not recruiting
90
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Right Handed
  • Single, Left Hemisphere Cerebrovascular Stroke
  • Must be 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
Both
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00608582
NIH-DC05672, R01DC005672, Boston Medical Ctr IRB-H22484, VA Boston Healthcare IRB-1145
No
Margaret A. Naeser, Ph.D., Neurology Dept., Boston Univ. Sch. Med.; VA Boston Healthcare System, JP Campus
Boston University
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Harvard University
  • 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
January 2013

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