AphasiaPhase 1NCT00608582
Transcranial Magnetic Stimulation to Improve Speech in Aphasia
A Phase 1 study testing Transcranial Magnetic Stimulation, Repetitive in people with Aphasia and Cerebrovascular Stroke, run by Boston University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Aphasia, Cerebrovascular Stroke
- What is being tested?
- Transcranial Magnetic Stimulation, Repetitive
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2002to Jun 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right Handed
- Single, Left Hemisphere Cerebrovascular Stroke
- Must be at least 6 months poststroke onset
- Native Speaker of English
- Clinical Diagnosis of Aphasia
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Boston Healthcare System, Jamaica Plain Campus, Boston University Aphasia Research Center (12-A), 150 So. Huntington Ave.
Boston, Massachusetts, 02130
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
Department of Neurology, Hospital of the University of Pennsylvania, 3 W. Gates Bldg.
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: 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.
Read the 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.
- Conditions
- Aphasia, Cerebrovascular Stroke
- Being tested
- Transcranial Magnetic Stimulation, Repetitive
- Keywords
- Transcranial Magnetic Stimulation, Repetitive, TMS, Treat Naming, Aphasia, Chronic Stroke, Randomized, Controlled Trial
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation, RepetitiveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial Magnetic Stimulation, Repetitive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Picture Naming
Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures
Measured: 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
Measured: Baseline and 2 months after the last rTMS treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJul 2002
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Harvard Medical School (HMS and HSDM), University of Pennsylvania
- Responsible party
- Principal investigator, Margaret Naeser, Boston University
- Investigators
- Margaret A Naeser, Ph.D., Study chair, Department of Neurology, Boston University School of Medicine, Boston, MAH B Coslett, M.D., Principal investigator, Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PAAlvaro Pascual-Leone, M.D., Ph.D., Principal investigator, Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608582
- Sponsor's protocol ID
- NIH-DC05672
- Other IDs
- R01DC005672, Boston Medical Ctr IRB-H22484, VA Boston Healthcare IRB-1145
- Status last verified
- Dec 2016
- First submitted
- 24 Jan 2008
- Last updated
- 31 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19818232Naeser 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.
PubMed 20714075Hamilton 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.
PubMed 21459427Chrysikou 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.
PubMed 22124035Naeser 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.
PubMed 22202188Torres 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.
PubMed 23719561Garcia 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.
PubMed 23852365Naeser 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.
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.
PubMed 15118944Naeser 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.
PubMed 15766771Naeser 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.
PubMed 16006338Martin 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.
PubMed 19695692Naeser 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.
PubMed 20299861Hamilton 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.
PubMed 20159655Naeser 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.
PubMed 21864891
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation to Improve Speech
- ClinicalTrials.gov ID
- NCT00608582
- Acronym / sponsor ID
- NIH-DC05672
- Conditions
- Aphasia, Cerebrovascular Stroke
- Keywords
- Transcranial Magnetic Stimulation, Repetitive, TMS, Treat Naming, Aphasia, Chronic Stroke, Randomized, Controlled Trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Harvard Medical School (HMS and HSDM), University of Pennsylvania
- Study start
- Jul 2002
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 31 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS | Experimental | Device: Transcranial Magnetic Stimulation, RepetitiveThese 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. |
| Sham rTMS | Sham comparator | Device: Transcranial Magnetic Stimulation, RepetitivePatients 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Right Handed
- Single, Left Hemisphere Cerebrovascular Stroke
- Must be at least 6 months poststroke onset
- Native Speaker of English
- Clinical Diagnosis of Aphasia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation, Repetitive10 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. | Device | Real rTMS, Sham rTMS |
Primary outcome
Picture Naming
Time frame: Baseline and 2 months after the last rTMS treatment session
Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures
Phrase Length
Time frame: Baseline and 2 months after the last rTMS treatment session
Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19818232Martin 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.
- Background: PubMed 20714075Naeser 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.
- Background: PubMed 21459427Hamilton 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.
- Background: PubMed 22124035Chrysikou 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.
- Background: PubMed 22202188Naeser 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.
- Background: PubMed 23719561Torres 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.
- Background: PubMed 23852365Garcia 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.
- BackgroundNaeser 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.
- Results publication: PubMed 15118944Martin 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.
- Results publication: PubMed 15766771Naeser 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.
- Results publication: PubMed 16006338Naeser 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.
- Results publication: PubMed 19695692Martin 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.
- Aphasia Research Lab of Margaret A. Naeser, Ph.D., VA Boston Healthcare System and Dept. of Neurology, Boston University School of Medicine, Boston, MALink provided by the sponsor.
- Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Dept. of Neurology, Harvard Medical School, Boston, MALink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret A Naeser, Ph.D. study chair
Department of Neurology, Boston University School of Medicine, Boston, MA
H B Coslett, M.D. principal investigator
Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA
Alvaro Pascual-Leone, M.D., Ph.D. principal investigator
Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial Magnetic Stimulation, Repetitive in people with Aphasia and Cerebrovascular Stroke, run by Boston University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picture Naming (time frame: Baseline and 2 months after the last rTMS treatment session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00608582, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.