Transcranial Magnetic Stimulation to Improve Speech in Aphasia
Condition: Aphasia; Cerebrovascular Stroke
MeSH terms: Stroke; Aphasia
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

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.
    

Intervention name(s): Transcranial Magnetic Stimulation, Repetitive
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation, Repetitive; TMS; Treat Naming; Aphasia; Chronic Stroke; Randomized, Controlled Trial