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TMS, H coil

Phase 2

Alzheimer's Disease | Unknown | Neurology |BrainsWay Ltd.|Last Updated: Jan 25, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

TMS, H coil · 1 trial · 1 indication

Phase 2 1
NCT01179373Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's DiseaseAlzheimer's Disease
COMPLETED45 Analytics
PHASE2COMPLETED
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

cognitive functioning score by ADAS-COG
4 months

Secondary Endpoints

Global advancement score by CGI-C
4 months
Frontal lobe functioning score by FAB
4 months
Daily activity score by ADL
4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TMS, High FrequencyACTIVE_COMPARATORHigh Frequency TMS with H coil to prefrontal cortex
TMS, Low FrequencyACTIVE_COMPARATORLow Frequency TMS to Prefrontal cortex
Sham StimulationPLACEBO_COMPARATORSham TMS with H Coil on Prefrontal Cortex

Interventions

NameTypeDescription
TMS, H coilDEVICETMS, H Coil, High/ Low Frequency
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Men and women aged 50-85. 2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria). 3. Scored below 24 on the MMSE. 4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 week...

Countries:Israel
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Frequently asked questions about TMS, H coil

What is TMS, H coil used for in Alzheimer's Disease?

TMS, H coil is an investigational deep transcranial magnetic stimulation device being studied for the treatment of Alzheimer's Disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The device is being evaluated for its potential to address symptoms of this neurological condition.

Who makes TMS, H coil?

TMS, H coil is being developed by BrainsWay Ltd., a company publicly traded under the ticker symbol BWAY. The company is conducting clinical research to evaluate this deep transcranial magnetic stimulation device for Alzheimer's Disease. BrainsWay is responsible for the ongoing development and potential commercialization of this investigational therapy.

What phase is TMS, H coil in?

TMS, H coil is currently in Phase 2 clinical development for Alzheimer's Disease. It is an investigational device that has not yet received regulatory approval. The Phase 2 trial has been completed, and the device remains under evaluation for safety and efficacy in this patient population.

What clinical trials is TMS, H coil in?

TMS, H coil has one completed Phase 2 clinical trial registered under NCT01179373, titled "Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease." This randomized, double-blind, placebo-controlled study enrolled 45 participants in Israel, with a minimum age of 50 years, and included both sexes.

Is TMS, H coil the same as deep transcranial magnetic stimulation?

TMS, H coil is a specific type of deep transcranial magnetic stimulation device. The clinical trial NCT01179373 evaluates this device for Alzheimer's Disease treatment. While TMS, H coil refers to the specific coil configuration used, deep transcranial magnetic stimulation is the broader technology category to which this device belongs.