The University of Iowa Hospitals and Clinics (UIHC) is now conducting a clinical trial focusing on the brain with the hope that the study could uncover a treatment for certain brain disorders. Called transcranial magnetic stimulation (TMS), the investigational treatment was approved by the FDA in 2008 for treatment of some forms of depression. UICH investigators will study whether the treatment can help with other brain disorders such as autism, bipolar disorder or schizophrenia.
The Study is Based on TMS
Already underway for about two years reports local ABC 9 News, the study is based on the use of TMS, a noninvasive method of focally stimulating the brain that uses electromagnetic induction and does not require surgery. The study sponsor, University of Iowa, notes there is an optimism that TMS will revolutionize how medical professionals will treat neurological and psychiatric disorders, evidenced by over 1,000 clinical trials registered using TMS.
Iowa believes much of this optimism stems from the use of TMS as a way to treat depression. However, despite a large number of TMS clinical trials, the number of actual therapeutic indications has been stagnant—limited to major depression and more recently obsessive-compulsive disorder.
What is TMS?
Transcranial magnetic stimulation (TMS) is an option used to treat patients with depression who do not respond to medications. The technique is a noninvasive option precluding the need for anesthesia or involving a scenario of memory loss. It doesn’t work for all patients. During the treatment, a magnetic field is produced to induce a small electric current in the brain tissue. When the TMS pulses are delivered at regular intervals it is called repetitive TMS (rTMS). Repetitive TMS can be applied daily to cause long-lasting changes in the brain. The Mayo Clinic reports on common side effects.
Fundamental Questions about TMS
UIHC understands that there are fundamental questions about the underlying mechanisms for TMS representing critical preconditions in the effort to ultimately advance this treatment modality. In an attempt to generate this knowledge researchers have formed a unique collaborative project between neurology and neurosurgery that is hoped will allow an unprecedented window into an understanding as to how TMS impacts the human brain.
The Heart of the Study
The Iowa collaboration will perform TMS in neurosurgical patients with intracranial electroencephalography (iEEG) monitoring to record real-time effects of TMS on local and remote brain areas with an unparalleled combination of a spatial and temporal resolution relative to other human clinical trials. The Iowa team touts in their Clinicaltrials.gov trial summary that they have already demonstrated the safety of this approach using a gel-based phantom brain and have already generated the results from seven patients evidencing safety and initial results.
The Iowa team is seeking to 1) characterize the response of the TMS on the human brain as recorded from iEEG between active and sham conditions and 2) relate remote electrophysiological responses from TMS to measures of brain connectivity between the stimulation & recording sites assessed with resting-state functional connectivity MRI (rs-fcMRI). This enables an evaluation of the relationship between TMS-evoked iEEG responses and the strength of the functional connectivity to the stimulation site in a regression model.
The Iowa team hypothesizes that 1) TMS will have focus effects detected from surface electrodes underlying the stimulation site as well as network-level engagement detected at remote sites; 2) repetitive TMS will induce frequency-specific effects that differ between 0.5 and 10 Hz stimulation protocols, and 3) the magnitude of repetitive TMS-evoked iEEG responses across electrodes will relate to the strength of rs-fcMRI between the stimulation and recording sites.
Aaron Boes, MD, Ph.D., University of Iowa
Call to Action: Do you have a family member or loved one struggling with mental disorders such as bipolar disorder where medications can’t seem to work? Perhaps TMS is an option. Look into the approach the research of University of Iowa Hospitals and Clinics.