Here is the design of a clinical trial:

Official Title: VertiGO! - Get up and GO! With the Vestibular Implant

Included conditions:
- Bilateral Vestibular Loss

Study Armgroups:
- {'label': 'ABC', 'type': 'OTHER', 'description': 'A = Baseline stimulation, no modulation\n\nB = Baseline stimulation, modulation stimulation\n\nC = Reduced baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}
- {'label': 'ACB', 'type': 'OTHER', 'description': 'A = Baseline stimulation, no modulation\n\nC = Reduced baseline stimulation, modulation stimulation\n\nB = Baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}
- {'label': 'BAC', 'type': 'OTHER', 'description': 'B = Baseline stimulation, modulation stimulation\n\nA = Baseline stimulation, no modulation\n\nC = Reduced baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}
- {'label': 'BCA', 'type': 'OTHER', 'description': 'B = Baseline stimulation, modulation stimulation\n\nC = Reduced baseline stimulation, modulation stimulation\n\nA = Baseline stimulation, no modulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}
- {'label': 'CAB', 'type': 'OTHER', 'description': 'C = Reduced baseline stimulation, modulation stimulation\n\nA = Baseline stimulation, no modulation\n\nB = Baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}
- {'label': 'CBA', 'type': 'OTHER', 'description': 'C = Reduced baseline stimulation, modulation stimulation\n\nB = Baseline stimulation, modulation stimulation\n\nA = Baseline stimulation, no modulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}

Interventions:
- {'type': 'DEVICE', 'name': 'Cochlear Vestibular Implant (CVI)', 'description': 'The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:\n\n* A - Baseline stimulation, no modulation stimulation\n* B - Baseline stimulation, modulated stimulation\n* C - Reduced baseline stimulation, modulated stimulation', 'armGroupLabels': ['ABC', 'ACB', 'BAC', 'BCA', 'CAB', 'CBA']}

Primary Outcomes:
- {'measure': 'Safety of vestibular stimulation via the CVI', 'description': "Amount of (S)AE's after implantation to determine safety of the device", 'timeFrame': 'Through full trial period, up to 5 years postoperatively'}
- {'measure': 'The feasibility of vestibular stimulation improving Dynamic Visual Acuity during walking', 'description': 'Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity while walking. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'The feasibility of vestibular stimulation improving Dynamic Visual Acuity during passive head movements', 'description': 'Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity during fast passive head movements measured with the functional Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'The feasibility of vestibular stimulation restoring the high-frequency vestibulo-ocular reflex', 'description': 'Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during fast passive head movements in the LHRH, RALP and LARP planes measured with the video Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'The feasibility of vestibular stimulation restoring the low-frequency vestibulo-ocular reflex', 'description': 'Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during slow, passive, full body rotations measured with the Torsion Swing test. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'The feasibility of vestibular stimulation improving the self-movement perception in dark', 'description': 'Evaluating whether vestibular stimulation (via the CVI) can improve self-motion perception measured by controlled motion stimuli delivered by a moving platform. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data', 'description': 'Evaluating the influence of vestibular stimulation (via the CVI) on walking patterns and stability based on motion capture data. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'The feasibility of vestibular stimulation improving balance based on clinical evaluation', 'description': 'Clinical evaluation of the influence of vestibular stimulation (via the CVI) on balance measured with the MiniBESTest. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'Speech perception with CVI in quiet without simultaneous vestibular stimulation', 'description': 'Evaluating hearing performance with the CVI based on speech perception in quiet measured with an aided consonant-nucleus-consonant word test, without simultaneous vestibular stimulation', 'timeFrame': 'Through the full trial period, until 5 years after implantation'}
- {'measure': 'Interaction between vestibular and cochlear stimulation on speech perception in quiet', 'description': 'Evaluating hearing performance with the CVI based on speech perception in quiet while simultaneously providing vestibular stimulation, measured with an aided consonant-nucleus-consonant word test. The influence of each vestibular stimulation algorithm will be evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}
- {'measure': 'Speech perception with CVI in noise without simultaneous vestibular stimulation', 'description': 'Evaluating hearing performance with the CVI based on speech perception in noise measured with a sentence speech In noise test, without simultaneous vestibular stimulation', 'timeFrame': 'Through the full trial period, until 5 years after implantation'}
- {'measure': 'Change in otolith function due to CVI implantation', 'description': 'Evaluating the influence of CVI implantation on otolith function based on cVEMP and oVEMP responses post-operatively, comparing with the pre-operative situation.', 'timeFrame': 'preoperatively and 1 month postoperatively'}
- {'measure': 'Vestibular and cochlear electrode location', 'description': 'Evaluating the location and potential migration of the vestibular and cochlear electrodes of the CVI with cone-beam CT scans- of the mastoid.', 'timeFrame': 'Through the full trial period, until 5 years after implantation'}

Please estimate the sample size based on the assumption: 
Significance level (alpha) set at 0.05, power set at 0.80, and a two-sided Wilcoxon signed-rank test used for sample size calculation.
2.5 Sample size calculation
        Sample size calculation is based on the primary study outcome: DVA score (see 2.4.1). Visual acuity (VA) can be expressed in several different units. However, for data analysis it is important to use the logarithm of the minimum angle of resolution (logMAR), since this unit scales linearly with the geometric progression of the visual acuity chart [73]. Data from previous measurements on the influence of vestibular stimulation on DVA was used for the sample size calculation [19]. Although this data was obtained with a different version of VCI (which did not yet allow simultaneous VI and CI stimulation), it is the closest analog available to approximate the results of this trial. To account for the between-patient difference in VA, the data from the previous experiment, expressed in logMAR, were normalized to the static VA measured for each patient. This yields mean logMAR values of 0.065 (SD 0.061) and 0.205 (SD 0.066) for VI active and VI inactive, respectively. Since the size of the dataset is too small to determine whether or not the data is normally distributed, the sample size was calculated for a two-sided Wilcoxon signed-rank test. Significance level (alpha) was set at 0.05 and power was set at 0.80 [74, 75]. Both effect size and minimal sample size were calculated with G*Power 3.1.9.7 [76]. Effect size was determined to be 2.20, which resulted in a minimum sample size of five. Given the available resources (e.g. prototype hardware and software, budget limitations due to high (surgical) costs of the procedures) and to provide this statistical background with a safety margin, this trial will aim to include a minimum of eight, with a maximum of 13, patients. Although this is still a relatively small number, both safety and efficacy of the new prototype VCI is believed to be investigated thoroughly with this sample size due to the high frequency of measurements and a total follow-up duration of 5 years.