Here is the design of a clinical trial:

Official Title: A Phase I/II Open-label Multicenter Trial to Evaluate Safety and Preliminary Efficacy of Unilateral Deep Brain Stimulation of the Mesencephalic Locomotor Region in Patients With Incomplete Spinal Cord Injury

Included conditions:
- Spinal Cord Injury

Study Armgroups:
- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Single-armed study. All patients will receive treatment.', 'interventionNames': ['Procedure: Deep brain stimulation in mesencephalic locomotor region', 'Device: Implantation of a Deep brain stimulation system']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Deep brain stimulation in mesencephalic locomotor region', 'description': 'Implantation of Electrodes in the Mesencephalic Locomotor Region for improvement of Locomotion and Gait', 'armGroupLabels': ['Intervention group']}
- {'type': 'DEVICE', 'name': 'Implantation of a Deep brain stimulation system', 'description': 'Implantation of a Medtronic Percept PC Impulse Generator for chronic Stimulation of the selected target.', 'armGroupLabels': ['Intervention group']}

Primary Outcomes:
- {'measure': 'Change in 6 Minute Walk Test at baseline and 6 months post intervention', 'description': 'Standardized test. Patient is asked to walk for 6 minutes. Result is the distance covered', 'timeFrame': 'preoperative, 6 months post intervention'}

Please estimate the sample size based on the assumption: 
power (1-β) of 80%, α=0.05
Sample size
        Based on data on the 6MWT48 82 83 published in the literature and our clinical experience we estimate a relative effect size of 30% improvement in the 6MWT 6 months after treatment start compared with performance at baseline to be clinically relevant. A sample size of five patients provides us with a power (1âÎ²) of 80% (Î±=0.05). Founded on previous experience in DBS of the MLR,84 85 we judge that the selected sample size will provide acceptable clinical validity for the study objectives.