Here is the design of a clinical trial:

Official Title: A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease

Included conditions:
- Parkinson Disease

Study Armgroups:
- {'label': 'conventional DBS', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: AlphaDBS System']}
- {'label': 'adaptive DBS', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: AlphaDBS System']}

Interventions:
- {'type': 'DEVICE', 'name': 'AlphaDBS System', 'description': 'AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration.', 'armGroupLabels': ['adaptive DBS', 'conventional DBS']}

Primary Outcomes:
- {'measure': 'Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode', 'description': 'Occurrence of device related adverse events', 'timeFrame': '1 month'}

Please estimate the sample size based on the assumption: 
Type I error probability of 0.05, power of 99%, TEED=44.6 in aDBS, TEED=158.7 in cDBS, SD=100, and a higher SD observed multiplied by 4.5. The study will also observe adverse events occurring in 5%-10% of the patients, but not rare events in the range of 1%-2%.
Sample size
          The objective of the study is to collect data, such as the degree of correlation between GOT in aDBS and cDBS, that will allow calculation of the sample size needed for a pivotal study if this study confirms the results obtained in a previous trial. This study will randomise at least 15âpatients.
          Based on the figures obtained in the clinical trial with patients in the âacuteâ phase,25 and without considering corrections for multiple testing, this sample will allow using exploratory statistics to demonstrate a difference in TEED during cDBS and aDBS sessions through a non-parametric test for an effect size of 1.14, assuming the following parameters, using type I error probability equal to 0.05 and power of 99%: TEED=44.6 in aDBS, TEED=158.7 in cDBS, SD=100, multiplying by 4.5 the higher SD observed. Also, 15 patients will allow to observe AEs occurring in 5%â10% of the patients, but not rare events in the range 1%â2%. However, at this stage, rare hardware-related AEs (1%â2%) are not considered since they were already described by other DBS devices manufacturers and thus expected. Also, rare hardware related are usually observable in studies with longer observation periods than that included in this study (1âmonth) which is thus not ideal to assess this type of information, which in any case will be collected.