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Transcranial Magnetic Stimulation, Repetitive

Phase 1

Aphasia | Unknown | Other |Harvard Bioscience, Inc.|Last Updated: Jan 31, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindSHAM_CONTROLLEDBiomarker
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00608582Transcranial Magnetic Stimulation to Improve Speech in AphasiaPHASE1 COMPLETED 63Jul 1, 2002Jun 1, 2013Jan 31, 20173 United States
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Study Endpoints
Primary Endpoints
Picture Naming
Baseline and 2 months after the last rTMS treatment session

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

Phrase Length
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

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Real rTMSEXPERIMENTALThese 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 rTMSSHAM_COMPARATORPatients 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.
Interventions
NameTypeDescription
Transcranial Magnetic Stimulation, RepetitiveDEVICE10 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.
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Eligibility Criteria
Age Range45 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 dev...

Countries:United States
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