A Protocol to Enhance Therapeutic Effects of Transcranial Magnetic Stimulation and the Methods to Realize It

Summary: 

The National Institute on Drug Abuse (NIDA) seeks research co-development partners and/or licensees for a high-powered electronic device and coil that delivers Transcranial Magnetic Stimulation (TMS) pulses as well as the software that controls the device for treating treatment resistant depression, substance use disorders and other CNS disorders.

Description of Technology: 

Transcranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation technique recently cleared by the FDA as a therapy for treatment-resistant major depression, obsessive-compulsive disorder (OCD) and nicotine addiction. Stimulation is produced by passing a brief, strong electric current through a coil placed in close proximity to the patient’s head. The coil generates an electric field inside the patient’s brain, exciting or inhibiting a targeted region. Repetitive high-frequency TMS at 10 Hz (rTMS) was the first protocol cleared by FDA for depression treatment, while Intermittent Theta Burst Stimulation (iTBS) is a newer protocol recently cleared by the FDA. The rTMS protocol requires 37.5 min per treatment session compared with only 190 seconds for iTBS – making iTBS much more tolerable to a patient. The therapeutic efficacy between these two protocols is non-distinguishable. However, given the high voltages and currents required in iTBS (e.g., 50 Hz instead of 10 Hz), it is more challenging to implement. In addition, clinical efficacy of TMS treatment overall has been relatively modest, with only about one-third of the patients responding well to the treatment. Enhancing TMS treatment efficacy is of great medical value and broad interest.

Researchers at NIDA developed a novel TMS paradigm to enhance the effects of TMS treatment and, in addition, the machine to realize this paradigm. The invention allows specifying a variable number of pulses in each burst (e.g., up to 6 pulses per burst) and having an inter-burst interval of 200 ms (e.g., 5 Hz). The paradigm is based on iTBS but deliveries 6 pulses fixed per burst instead of 3. Thus, the number of TMS pulses delivered is effectively doubled in the same amount of time. Data from in vivo experiments using an awake rat model suggest that, compared with conventional iTBS protocol, this novel TMS paradigm enhance TMS after-effects by up to 92% versus conventional methods. This technology has the potential to greatly improve clinical outcomes of TMS treatment of depression and other neurological and/or psychiatric disorders.

The National Institute on Drug Abuse (NIDA) seeks research co-development partners and/or licensees to further develop and commercialize this technology.

Potential Commercial Applications: 

• Enhanced TMS therapeutic for treatment resistant depression (MDD)
• Enhanced TMS therapeutic for treatment resistant obsessive-compulsive disorder (OCD)
• Enhanced TMS therapeutic for treatment resistant nicotine addiction

Competitive Advantage:

• Novel TMS paradigm that can improve the outcome of TMS treatment
• The machine to deliver this paradigm has already been developed
• This technology delivers the high frequency pulses needed for TMS operations which occur at high current and high voltage (3000 Amperes and 2000 volts), which requires special expertise and is highly valuable
• This technology provides a new coil design, cooling, and fabrication strategy, and there is a need for new TMS coil development
• Prototypes have been developed for the technology and successfully validated in a rat modelc