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MagPro Double Blinded Research System

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Overview

professional system solution for double blinded clinical studies
MagVenture's system solution for double blinded clinical studies has been developed in response to requests from researchers wanting to perform double blinded multi-center studies in rTMS for depression. It addresses requirements for efficacy, accuracy and consistency. The system solution can naturally be used for double blinded studies in other research areas such as stroke rehabilitation 

  

Applications

  • Double blinded multi-center studies in rTMS for depression.

  System Components

  • Repetitive transcranial magnetic stimulator
  • Software MagLink
  • Butterfly coil C-B60 to determine MT
  • Special Coil Cool-B65 A/P
  • Chair with vacuum pillow (optional)

 

The two particular components specifically designed for the double-blind study are the special coil-Cool B65 A/P and software MagLink to manage the study protocol.

 

Butterfly coil Cool-B65 A/P

For treatments, MagLink will require use of the Cool-B65 A/P coil which has a built-in position sensor used to ensure that the correct (active or sham) side of the coil faces towards the patient's head. If the coil position is wrong the operator will get a "Flip Coil" prompt on the MagPro screen.  To ensure best possible blinding of patients the current stimulation provided with the Cool-B65 A/P coil should be used to stimulate the patient's skin.

Cool-B65 AP
    • Functions as both active (A) and placebo (P) coil and its symmetrical design with no indication of active vs. placebo side makes it ideal for double blinded studies.

    • Built-in orientation switch to determine which side of the coil to be placed towards the patient (screen prompt on the MagPro if used with the rTMS Research software)

  • Electrical and magnetic properties identical to the MCF-B65 and the Cool-B65 coils. Adjustable output for current stimulation of the patient's skin syncronously with the magnetic stimulation pulses.
     
Click here to see details about the coil Cool-B65 A/P

Cool-B65AP

Mechanical Properties

  • Weight of transducer head 3 kg
  • Dimensions of transducer head 174 x 94 x 80  mm
  • Cable length 1,3m

Coil Winding Data

  • Inner diameter: 35mm
  • Outer diameter: 75mm
  • Winding height: 12mm
  • Number of windings 2x (2 x 5)

 

 

Magnetic and Electrical Properties

  • Max initial dB/dt: 36 kT/s near the coil surface.
  • Active pulse width: 280µs (Biphasic)

Performance

  • Number of stimulations, before warm-up at ambient temperature 20°C, output 75% of maximum at 2pps. > 20.000 pulses
  • Number of stimulations, before warm-up at ambient temperature 20°C with protocol: 60 trains @  50 >10.000 pulses

pulses/train @ 10pps @ Inter Train Interval: 25s @ Output=75%.

  

MagLink Software

maglink patient key createdThe MagLink software program is used by the principal investigator to define the treatment protocol for each patient enrolled in the study. This includes defining whether a given patient is to receive real or sham treatment. When the protocol has been defined it is downloaded to a Patient Key (USB memory device) which is sent to the center/site where the patient is to receive treatment.

MagLink is also used to define the user rights of the individual operators - ranging from performing only the defined treatment protocol to full access to all stimulator functionalities when not  performing Motor Threshold (MT) determination or treatments according to the protocol. When performing MT or actual treatment of patients, both Operator Key and Patient Key need to be inserted in the two USB connectors on the MagPro.

When performing MT or actual treatment of patients, both Operator Key and Patient Key need to be inserted in the two USB connectors on the MagPro.

Click here to see MagLink software details

Information stored on the Operator Key 

maglink set operator create
 

Information stored in the USB Patient Key 

maglink patient key created
 

MagLink study report

maglink study report

 

Accessories

Neck-RestThe system can be equipped with some accessories to facilitate the tratment such as: the electrically adjustable Treatment Chair with neck rest, the vacuum pillow to stabilize the position of the head of the patient during treatment and the Textile Caps to mark the position for a magnetic coil on each patient and find the correct position of stimulation.

 

 

Product informations request formeuro small 

 

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