Expired Study
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Boston, Massachusetts 02215


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.


Study summary:

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.


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


Study is Available At:


Original ID:

NIH-DC05672


NCT ID:

NCT00608582


Secondary ID:

R01DC005672


Study Acronym:


Brief Title:

Transcranial Magnetic Stimulation to Improve Speech in Aphasia


Official Title:

Transcranial Magnetic Stimulation to Improve Speech


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

45 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

63


Enrollment Type:

Actual


Overall Contact Information

Official Name:Margaret A Naeser, Ph.D.
Study Chair
Department of Neurology, Boston University School of Medicine, Boston, MA

Study Dates

Start Date:July 2002
Completion Date:June 2013
Completion Type:Actual
Primary Completion Date:June 2013
Primary Completion Type:Actual
Verification Date:January 2015
Last Changed Date:January 29, 2015
First Received Date:January 24, 2008

Study Outcomes

Outcome Type: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Transcranial Magnetic Stimulation, Repetitive
Description: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.
Arm Name:Real rTMS

Study Arms

Study Arm Type:Experimental
Arm Name:Real rTMS
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Deafness and Other Communication Disorders (NIDCD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Martin PI, Naeser MA, Theoret H, Tormos JM, Nicholas M, Kurland J, Fregni F, Seekins H, Doron K, Pascual-Leone A. Transcranial magnetic stimulation as a complementary treatment for aphasia. Semin Speech Lang. 2004 May;25(2):181-91. Review.
PMID:15118944
Reference Type:Results Reference
Citation:Naeser MA, Martin PI, Nicholas M, Baker EH, Seekins H, Kobayashi M, Theoret H, Fregni F, Maria-Tormos J, Kurland J, Doron KW, Pascual-Leone A. Improved picture naming in chronic aphasia after TMS to part of right Broca's area: an open-protocol study. Brain Lang. 2005 Apr;93(1):95-105.
PMID:15766771
Reference Type:Results Reference
Citation:Naeser MA, Martin PI, Nicholas M, Baker EH, Seekins H, Helm-Estabrooks N, Cayer-Meade C, Kobayashi M, Theoret H, Fregni F, Tormos JM, Kurland J, Doron KW, Pascual-Leone A. Improved naming after TMS treatments in a chronic, global aphasia patient--case report. Neurocase. 2005 Jun;11(3):182-93.
PMID:16006338
Reference Type:Results Reference
Citation:Martin PI, Naeser MA, Ho M, Treglia E, Kaplan E, Baker EH, Pascual-Leone A. Research with transcranial magnetic stimulation in the treatment of aphasia. Curr Neurol Neurosci Rep. 2009 Nov;9(6):451-8. Review.
PMID:19818232
Reference Type:Results Reference
Citation:Martin PI, Naeser MA, Ho M, Doron KW, Kurland J, Kaplan J, Wang Y, Nicholas M, Baker EH, Alonso M, Fregni F, Pascual-Leone A. Overt naming fMRI pre- and post-TMS: Two nonfluent aphasia patients, with and without improved naming post-TMS. Brain Lang. 2009 Oct;111(1):20-35. doi: 10.1016/j.bandl.2009.07.007. Epub 2009 Aug 19. Erratum in: Brain Lang. 2010 Feb;112(2):135. Alonso, Miguel [added].
PMID:19695692
Reference Type:Results Reference
Citation:Naeser MA, Martin PI, Lundgren K, Klein R, Kaplan J, Treglia E, Ho M, Nicholas M, Alonso M, Pascual-Leone A. Improved language in a chronic nonfluent aphasia patient after treatment with CPAP and TMS. Cogn Behav Neurol. 2010 Mar;23(1):29-38. doi: 10.1097/WNN.0b013e3181bf2d20.
PMID:20299861
Reference Type:Results Reference
Citation:Naeser MA, Martin PI, Treglia E, Ho M, Kaplan E, Bashir S, Hamilton R, Coslett HB, Pascual-Leone A. Research with rTMS in the treatment of aphasia. Restor Neurol Neurosci. 2010;28(4):511-29. doi: 10.3233/RNN-2010-0559. Review.
PMID:20714075
Reference Type:Results Reference
Citation:Hamilton RH, Sanders L, Benson J, Faseyitan O, Norise C, Naeser M, Martin P, Coslett HB. Stimulating conversation: enhancement of elicited propositional speech in a patient with chronic non-fluent aphasia following transcranial magnetic stimulation. Brain Lang. 2010 Apr;113(1):45-50. doi: 10.1016/j.bandl.2010.01.001. Epub 2010 Feb 16. Erratum in: Brain Lang.2010 May;113(2):101.
PMID:20159655

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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