Skip to content

Transcranial Magnetic Stimulation to Improve Speech in Aphasia

Transcranial Magnetic Stimulation to Improve Speech

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00608582
Enrollment
63
Registered
2008-02-06
Start date
2002-07-31
Completion date
2013-06-30
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Cerebrovascular Stroke

Keywords

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

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.

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.

Interventions

DEVICETranscranial 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.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
Harvard Medical School (HMS and HSDM)
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Right Handed * Single, Left Hemisphere Cerebrovascular Stroke * Must be at least 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

Design outcomes

Primary

MeasureTime frameDescription
Picture NamingBaseline and 2 months after the last rTMS treatment sessionPictures named correctly on Boston Naming Test (BNT), First 20 Pictures
Phrase LengthBaseline and 2 months after the last rTMS treatment sessionLongest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description

Countries

United States

Participant flow

Recruitment details

July 2002-March 2013. Recruited in hospital setting and outreach with affiliated and local clinics VA Boston Healthcare System, Boston, MA; Hospital of the University of Pennsylvania, Philadelphia, PA

Pre-assignment details

Assessed for eligibility by telephone screen, or in-office visit. Assessment included review of medical history. Total Excluded (n = 38) Not meeting inclusion criteria (n = 31) Declined to participate (n = 2) Other reasons (n = 5)

Participants by arm

ArmCount
Real rTMS
These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment. 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.
14
Sham rTMS
These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil. The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment. 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.
11
Total25

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyEarly stage Design Change03
Overall StudyIllicit Drug Use10
Overall StudyLost to Follow-up20
Overall StudyNo Best Response in Phase 1 located11

Baseline characteristics

CharacteristicTotalReal rTMSSham rTMS
Age, Continuous59.28 years
STANDARD_DEVIATION 9.1
58.1 years
STANDARD_DEVIATION 7.6
60.8 years
STANDARD_DEVIATION 11
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants14 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gender
Female
5 Participants3 Participants2 Participants
Gender
Male
20 Participants11 Participants9 Participants
Months Poststroke Onset59 months
STANDARD_DEVIATION 39
66 months
STANDARD_DEVIATION 40
51 months
STANDARD_DEVIATION 37
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
24 Participants13 Participants11 Participants
Region of Enrollment
United States
25 Participants14 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 140 / 11
serious
Total, serious adverse events
0 / 140 / 11

Outcome results

Primary

Phrase Length

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

Time frame: Baseline and 2 months after the last rTMS treatment session

Population: Chronic Stroke Patients with Aphasia who received either Real rTMS or Sham rTMS

ArmMeasureGroupValue (MEAN)Dispersion
Real rTMSPhrase LengthBaseline5.2 number of words per phrase lengthStandard Deviation 3.05
Real rTMSPhrase Length2 Mo. Post rTMS5.7 number of words per phrase lengthStandard Deviation 3.02
Sham rTMSPhrase LengthBaseline5.285 number of words per phrase lengthStandard Deviation 3.35
Sham rTMSPhrase Length2 Mo. Post rTMS5.0 number of words per phrase lengthStandard Deviation 3
Comparison: A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).p-value: 0.414ANOVA
Comparison: A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).p-value: <0.822ANOVA
Comparison: A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).p-value: <0.835ANOVA
Primary

Picture Naming

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

Time frame: Baseline and 2 months after the last rTMS treatment session

Population: Chronic Stroke Patients with Aphasia who receive either a Real rTMS series or a Sham rTMS series

ArmMeasureGroupValue (MEAN)Dispersion
Real rTMSPicture NamingBaseline10.3 number of picturesStandard Deviation 6.11
Real rTMSPicture Naming2 Mo. Post rTMS12.1 number of picturesStandard Deviation 5.55
Sham rTMSPicture Naming2 Mo. Post rTMS11.14 number of picturesStandard Deviation 3.24
Sham rTMSPicture NamingBaseline12.57 number of picturesStandard Deviation 5.88
Comparison: A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).p-value: <0.028ANOVA
Comparison: Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.p-value: <0.05t-test, 2 sided
Comparison: Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.p-value: <0.237t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026