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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: July 2002
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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. 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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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
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
VA Boston Healthcare System, Jamaica Plain Campus, Boston University Aphasia Research Center (12-A), 150 So. Huntington Ave.
Boston, Massachusetts, United States, 02130
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
Harvard University
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margaret A. Naeser, Ph.D., Neurology Dept., Boston Univ. Sch. Med.; VA Boston Healthcare System, JP Campus
ClinicalTrials.gov Identifier: NCT00608582     History of Changes
Other Study ID Numbers: NIH-DC05672, R01DC005672, Boston Medical Ctr IRB-H22484, VA Boston Healthcare IRB-1145
Study First Received: January 24, 2008
Last Updated: January 9, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 23, 2014