The COGNITION study rationale and design: influence of closed loop stimulation on cognitive performance in pacemaker patients.

Background: Several studies showed the beneficial effect of pacemaker implantation on cognitive performance in patients with bradycardia. But it has never been investigated if patients with chronotropic incompetence may improve their cognitive performance if treated by a rate-adaptive system reacting to mental stress in comparison to the most frequently used accelerometer-driven pacing.
Methods: The randomized, single-blind, multicenter COGNITION study evaluates if closed loop stimulation (CLS) offers incremental benefit in the speed of cognitive performance and the overall well-being of elderly patients with bradycardia compared with accelerometer-based pacing. Four hundred chronotropically incompetent patients older than 55 years will be randomized 3-6 weeks after implantation to CLS or accelerometer sensor. Follow-up visits are performed after 12 and 24 months. The speed of cognitive performance, which is the underlying function influencing all other aspects of cognitive performance, will be assessed by the number connection test, a standardized psychometric test for the elderly. Secondary endpoints include patient self-assessment of different aspects of health (by visual analogue scales), quality of life (by SF-8 health survey), the incidence of atrial fibrillation (episodes lasting for longer than 24 hours), and the frequency of serious adverse events.
Conclusion: In the ongoing COGNITION study, we aim at long-term comparison of two rate-adaptive systems, focusing on the cognitive performance of the patients, which was neglected in the past evaluation of pacemaker sensors.