This clinical trial tests the effectiveness of at home (remote) supervised transcranial direct current stimulation (rs-tDCS) as tool to decrease distress and decrease tobacco smoking in cancer survivors. Cigarette smoking is the strongest modifiable risk factor for cancer deaths among survivors. Unfortunately, the psychological distress associated with a cancer diagnosis makes smoking cessation challenging. TDCS is a noninvasive form of brain stimulation that delivers a minimal electric current delivered to the brain using sponge electrodes attached to the scalp which may affect brain activity to produce behavioral changes in smokers. Using rs-tDCS may reduce distress and decrease tobacco smoking in cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05460676.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Merideth A. Addicott
Phone: 336-716-7792
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of RS-tDCS as a therapeutic approach to smoking cessation in cancer survivors.
II. Evaluate preliminary efficacy of RS-tDCS as a tool to decrease distress (Sub Aim 2A) and decrease cigarette use in cancer survivors (Sub Aim 2B).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo at home rs-tDCS daily (QD) for 20 sessions. Patients also receive telehealth visits daily to oversee the rs-tDCS sessions. Additionally, patients receive concurrent mindfulness meditation practice using the study-provided tablet on study.
ARM II: Patients undergo at home sham rs-tDCS QD for 20 sessions. Patients also receive telehealth visits daily to oversee the rs-tDCS sessions. Additionally, patients receive concurrent mindfulness meditation practice using the study-provided tablet on study.
After completion of study intervention, patients are followed up at 2 and 4 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorMerideth A. Addicott