To test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-100M and supportive treatment compared to supportive treatment alone.
Participants will be randomized to the Supportive Care Group and will receive radiosurgery followed by supportive care, or to the NovoTTF-110M group who will receive radiosurgery then begin using the study device with supportive care. The device is to be worn at least 18 hours every day. There is a provision for those randomized to the supportive care arm to crossover to the study device after tumor has recurred twice. All participants will be seen every 8 weeks in the clinic until they progress a second time. Once study treatment is terminated, they will return to the clinic 8 weeks following the last visit, then be contacted once per month by telephone.
In this study, we plan to record electric fields (EF) in the brain while transcranial direct current stimulation (tDCS) is applied through the scalp. We will include patients who are scheduled to undergo deep brain stimulation (DBS) procedure to participate in the study, after explaining the procedures, answering any questions and receiving informed consent. The study might prolong the duration of the DBS procedure by a few minutes because of the time taken to apply tDCS. However, no other deviations from standard DBS procedures will be made. That is, no additional DBS electrode penetrations will be performed for research purposes - we will record from DBS electrodes that are being inserted exclusively as a part of clinical care.
This research is being conducted at the Medical University of South Carolina Institute of Psychiatry Brain Stimulation Lab by Dr. Mark George to see if deep repetitive transcranial magnetic stimulation (dTMS) is effective in assisting participants to quit smoking. TMS is a noninvasive medical procedure that uses magnetic fields to stimulate nerve cells in the brain to act as an aid to smoking cessation. The treatment period will involve 18 active/sham treatments to be given daily for 3 weeks then weekly treatments in week 4, 5, and 6. A follow up visit will be scheduled about 2 1/2 months after week 6. The entire study is four months in duration. Participants who may be recruited into the study would include the following: men and women 22-70 years of age, chronic; heavy smokers who have smoked for more than 1 year, with no period of abstinence greater than 3 months during the past year; subjects who are motivated to quit smoking; subjects who have negative answers on the TASS; and those who are able to sign an informed consent.