Functional MRI following Transcranial Direct Current Stimulation (tDCS)

Requirements rev5 Functional MRI following Transcranial Direct Current Stimulation (tDCS) 2.0 BACKGROUND As part of the ongoing study protocol, “The Effects of Transcranial Direct Current Stimulation on Food Intake and Weight Loss” (ClinicalTrials.gov Identifier NCT00739362), the Obesity and Diabetes Clinical Research Section of the Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, located at 850 North 5th Street, 7th Floor, Phoenix, Arizona 85004, requires functional magnetic resonance imaging of the brain to be performed before and after transcranial direct current stimulation.

The required services include acquisition of high-quality functional magnetic resonance imaging data, image preprocessing, quality control, and statistical analysis performed by personnel with demonstrated expertise in neuroimaging methods. These services are necessary to evaluate changes in brain activity associated with transcranial direct current stimulation, confirm engagement of the intended brain regions, and support the scientific objectives of the clinical research protocol.

3.0 OBJECTIVE The objective of this study is to evaluate the effects of transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex on brain activity and food intake. Functional magnetic resonance imaging will be performed before and after stimulation to confirm target engagement and measure changes in neural activity associated with the intervention.

4.0 CONTRACTOR REQUIREMENTS The contractor shall provide functional magnetic resonance imaging services consisting of four functional magnetic resonance imaging scans of the brain (two scans per session for two study participants) and analysis of the completed imaging data. The required services shall include:

Image preprocessing and validation. Data transfer, processing, and quality control. Region of interest and whole-brain statistical analysis. Preparation and delivery of a written analysis report summarizing the imaging results. The contractor shall provide the National Institutes of Health with copies of all acquired neuroimaging data and all processed imaging data and analysis results in a format compatible with the National Institutes of Health's available neuroimaging software. The National Institutes of Health shall be responsible for data management and long-term storage following delivery and acceptance of the final results. The period of performance is 08/31/2026-08/30/2027