Transcranial Magnetic Stimulation to Improve Speech in Aphasia

NCT00608582 | Completed Phase 1 Results

• 4 other identifiers: NIH-DC05672R01DC005672Boston Medical Ctr IRB-H22484VA Boston Healthcare IRB-1145
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Aphasia; Cerebrovascular Stroke

Keywords

Transcranial Magnetic Stimulation, Repetitive; TMS; Treat Naming; Aphasia; Chronic Stroke; Randomized, Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Picture Naming

  Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures

  Baseline and 2 months after the last rTMS treatment session

• Phrase Length

  Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description

  Baseline and 2 months after the last rTMS treatment session

Study Arms (2)

Real rTMS

EXPERIMENTAL

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.

Device: Transcranial Magnetic Stimulation, Repetitive

Sham rTMS

SHAM COMPARATOR

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.

Device: Transcranial Magnetic Stimulation, Repetitive

Interventions

Transcranial Magnetic Stimulation, Repetitive DEVICE

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.

Real rTMS; Sham rTMS

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right Handed
• Single, Left Hemisphere Cerebrovascular Stroke
• Must be at least 6 months poststroke onset
• Native Speaker of English
• Clinical Diagnosis of Aphasia

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

VA Boston Healthcare System, Jamaica Plain Campus, Boston University Aphasia Research Center (12-A), 150 So. Huntington Ave.

Boston, Massachusetts, 02130, United States

Location

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, 02215, United States

Location

Department of Neurology, Hospital of the University of Pennsylvania, 3 W. Gates Bldg.

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Publications (18)

• 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. doi: 10.1007/s11910-009-0067-9.

  PMID: 19818232 BACKGROUND

• 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.

  PMID: 20714075 BACKGROUND

• Hamilton RH, Chrysikou EG, Coslett B. Mechanisms of aphasia recovery after stroke and the role of noninvasive brain stimulation. Brain Lang. 2011 Jul;118(1-2):40-50. doi: 10.1016/j.bandl.2011.02.005. Epub 2011 Apr 2.

  PMID: 21459427 BACKGROUND

• Chrysikou EG, Hamilton RH. Noninvasive brain stimulation in the treatment of aphasia: exploring interhemispheric relationships and their implications for neurorehabilitation. Restor Neurol Neurosci. 2011;29(6):375-94. doi: 10.3233/RNN-2011-0610.

  PMID: 22124035 BACKGROUND

• Naeser MA, Martin PI, Ho M, Treglia E, Kaplan E, Bashir S, Pascual-Leone A. Transcranial magnetic stimulation and aphasia rehabilitation. Arch Phys Med Rehabil. 2012 Jan;93(1 Suppl):S26-34. doi: 10.1016/j.apmr.2011.04.026.

  PMID: 22202188 BACKGROUND

• Torres J, Drebing D, Hamilton R. TMS and tDCS in post-stroke aphasia: Integrating novel treatment approaches with mechanisms of plasticity. Restor Neurol Neurosci. 2013;31(4):501-15. doi: 10.3233/RNN-130314.

  PMID: 23719561 BACKGROUND

• Garcia G, Norise C, Faseyitan O, Naeser MA, Hamilton RH. Utilizing repetitive transcranial magnetic stimulation to improve language function in stroke patients with chronic non-fluent aphasia. J Vis Exp. 2013 Jul 2;(77):e50228. doi: 10.3791/50228.

  PMID: 23852365 BACKGROUND

• Naeser MA, Martin PI, Ho M, Treglia E, Kaplan E, Baker EH, and Pascual-Leone A. Transcranial Magnetic Stimulation and Aphasia Research. Book Chapter, Advances in the Neural Substrates of Language: Toward a Synthesis of Basic Science and Clinical Research. Vol 2: Language Processing in the Brain: Special Populations. Miriam Faust (Ed.), Malden, MA: Wiley-Blackwell, 2012.

  BACKGROUND

• 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. doi: 10.1055/s-2004-825654.

  PMID: 15118944 RESULT

• 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. doi: 10.1016/j.bandl.2004.08.004.

  PMID: 15766771 RESULT

• 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. doi: 10.1080/13554790590944663.

  PMID: 16006338 RESULT

• 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.

  PMID: 19695692 RESULT

• 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 RESULT

• 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.

  PMID: 20159655 RESULT

• Naeser MA, Martin PI, Theoret H, Kobayashi M, Fregni F, Nicholas M, Tormos JM, Steven MS, Baker EH, Pascual-Leone A. TMS suppression of right pars triangularis, but not pars opercularis, improves naming in aphasia. Brain Lang. 2011 Dec;119(3):206-13. doi: 10.1016/j.bandl.2011.07.005. Epub 2011 Aug 23.

  PMID: 21864891 RESULT

• Turkeltaub PE, Coslett HB, Thomas AL, Faseyitan O, Benson J, Norise C, Hamilton RH. The right hemisphere is not unitary in its role in aphasia recovery. Cortex. 2012 Oct;48(9):1179-86. doi: 10.1016/j.cortex.2011.06.010. Epub 2011 Jun 30.

  PMID: 21794852 RESULT

• Medina J, Norise C, Faseyitan O, Coslett HB, Turkeltaub PE, Hamilton RH. Finding the Right Words: Transcranial Magnetic Stimulation Improves Discourse Productivity in Non-fluent Aphasia After Stroke. Aphasiology. 2012 Sep 1;26(9):1153-1168. doi: 10.1080/02687038.2012.710316. Epub 2012 Aug 29.

  PMID: 23280015 RESULT

• Harvey DY, Podell J, Turkeltaub PE, Faseyitan O, Coslett HB, Hamilton RH. Functional Reorganization of Right Prefrontal Cortex Underlies Sustained Naming Improvements in Chronic Aphasia via Repetitive Transcranial Magnetic Stimulation. Cogn Behav Neurol. 2017 Dec;30(4):133-144. doi: 10.1097/WNN.0000000000000141.

  PMID: 29256908 DERIVED

Related Links

• Aphasia Research Lab of Margaret A. Naeser, Ph.D., VA Boston Healthcare System and Dept. of Neurology, Boston University School of Medicine, Boston, MA
• Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Dept. of Neurology, Harvard Medical School, Boston, MA

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Margaret Naeser, PhD
• Organization: VA Boston Healthcare System and Boston University School of Medicine

mnaeser@bu.edu

857-364-4030

Study Officials

• Margaret A Naeser, Ph.D.

  Department of Neurology, Boston University School of Medicine, Boston, MA

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Neurology

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 6, 2008
• Study Start: July 1, 2002
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 31, 2017
• Results First Posted: January 31, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)