Clinical trial NCT03811301: [BrainConnexion] - Neurodevice Phase I Trial
Official title: Neurodevice Phase I: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tetraplegia
Tetraplegia/Tetraparesis
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Locked-in Syndrome
Muscular Dystrophies
Lead sponsor: National Neuroscience Institute
Sponsor class: OTHER
Collaborators: name: Institute of Microelectronics
name: Institute of Molecular and Cell Biology
name: Institute for Infocomm Research
name: Nanyang Technological University
First posted: 2019-01-22
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to evaluate the safety of a wireless implantable neurodevice microsystem in tetraplegic patients, as well as the efficacy of the electrodes for long-term recording of neural activities and the successful control of an external device.

Detailed description: The goal of this study is to develop a miniaturized wireless implantable neurodevice microsystem that records and transmits signals from the motor cortex of tetraplegic patients, bypassing the damaged nervous tissue, to control an external assistive device that restores some form of independence to patients in terms of communication or mobility.

Eligibility criteria: Inclusion Criteria:

1. 21 years old and older
2. Tetraparesis
3. Written informed consent obtained from the patient or legal representative (in the event where the patient is unable to provide consent) prior to entry into the study in accordance with local EC/IRB regulations and/or other application regulations for surrogate consent.
4. Able to perform the pre-operation Brain Computer Interface training as judged by the research team.

Exclusion Criteria:

1. Significant medical co-morbidities e.g. cardiac disease
2. Bleeding disorders
3. Any contraindication to surgery
4. Other concomitant intracranial pathologies
5. History of seizures or epilepsy disorder
6. Complications of coagulopathy
7. Surgically unfit
8. Significant psychological issues e.g. Depression
9. Poor psychological support
10. Pregnancy
11. No means of communication
12. Any disease, in the opinion of the Investigator, that is unstable or which could jeopardise the safety of the patient

If applicable, psychological assessment may be performed prior to selection as the implantation process will be a long a stressful event, requiring a significant degree of patient cooperation and resilience.

Primary outcomes:
measure: The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation.
timeFrame: 6 months post-implant
Secondary outcomes:
measure: The signal quality of the electrodes for long-term recording of neural signals.
timeFrame: Day 1 to Day 365 post-implant
measure: Decoding accuracy per training session.
timeFrame: Day 1 to Day 365 post-implant
measure: Number of successful trials per session
timeFrame: Day 1 to Day 365 post-implant
measure: Time taken to complete each trial per session
timeFrame: Day 1 to Day 365 post-implant
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Neuroscience Institute
Study officials:
References:
citation: Libedinsky C, So R, Xu Z, Kyar TK, Ho D, Lim C, Chan L, Chua Y, Yao L, Cheong JH, Lee JH, Vishal KV, Guo Y, Chen ZN, Lim LK, Li P, Liu L, Zou X, Ang KK, Gao Y, Ng WH, Han BS, Chng K, Guan C, Je M, Yen SC. Independent Mobility Achieved through a Wireless Brain-Machine Interface. PLoS One. 2016 Nov 1;11(11):e0165773. doi: 10.1371/journal.pone.0165773. eCollection 2016.
citation: Hochberg LR, Serruya MD, Friehs GM, Mukand JA, Saleh M, Caplan AH, Branner A, Chen D, Penn RD, Donoghue JP. Neuronal ensemble control of prosthetic devices by a human with tetraplegia. Nature. 2006 Jul 13;442(7099):164-71. doi: 10.1038/nature04970.
citation: Hochberg LR, Bacher D, Jarosiewicz B, Masse NY, Simeral JD, Vogel J, Haddadin S, Liu J, Cash SS, van der Smagt P, Donoghue JP. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012 May 16;485(7398):372-5. doi: 10.1038/nature11076.
citation: Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. High-performance neuroprosthetic control by an individual with tetraplegia. Lancet. 2013 Feb 16;381(9866):557-64. doi: 10.1016/S0140-6736(12)61816-9. Epub 2012 Dec 17.
citation: Aflalo T, Kellis S, Klaes C, Lee B, Shi Y, Pejsa K, Shanfield K, Hayes-Jackson S, Aisen M, Heck C, Liu C, Andersen RA. Neurophysiology. Decoding motor imagery from the posterior parietal cortex of a tetraplegic human. Science. 2015 May 22;348(6237):906-10. doi: 10.1126/science.aaa5417.
citation: Schwarz DA, Lebedev MA, Hanson TL, Dimitrov DF, Lehew G, Meloy J, Rajangam S, Subramanian V, Ifft PJ, Li Z, Ramakrishnan A, Tate A, Zhuang KZ, Nicolelis MA. Chronic, wireless recordings of large-scale brain activity in freely moving rhesus monkeys. Nat Methods. 2014 Jun;11(6):670-6. doi: 10.1038/nmeth.2936. Epub 2014 Apr 28.
citation: Yin M, Borton DA, Komar J, Agha N, Lu Y, Li H, Laurens J, Lang Y, Li Q, Bull C, Larson L, Rosler D, Bezard E, Courtine G, Nurmikko AV. Wireless neurosensor for full-spectrum electrophysiology recordings during free behavior. Neuron. 2014 Dec 17;84(6):1170-82. doi: 10.1016/j.neuron.2014.11.010. Epub 2014 Dec 4.
citation: Zaaroor M, Kosa G, Peri-Eran A, Maharil I, Shoham M, Goldsher D. Morphological study of the spinal canal content for subarachnoid endoscopy. Minim Invasive Neurosurg. 2006 Aug;49(4):220-6. doi: 10.1055/s-2006-948000.
citation: Lee, K., Singh, A., He, J., Massia, S., Kim, B., & Raupp, G. (2004). Polyimide based neural implants with stiffness improvement. Sensors Actuators B Chem,102(1), 67-72. doi: 10.1016/j.snb.2003.10.018.
citation: Cheng, M. Y., Je, M., Tan, K. L., et al. (2013). A low-profile three-dimensional neural probe array using a silicon lead transfer structure. J Micromechanics Microengineering, 23(9), 095013. doi:10.1088/0960-1317/23/9/095013.
citation: Cheng, M. Y., Yao, L., Tan, K. L., Lim, R., Li, P., & Chen, W. (2014). 3D probe array integrated with a front-end 100-channel neural recording ASIC. J Micromechanics Microengineering, 24(12), 125010. doi:10.1088/0960-1317/24/12/125010.
citation: Zou, X., Liu, L., Cheong, J. H., et al. (2013). A 100-Channel 1-mW implantable neural recording IC. IEEE Trans Circuits Syst I Regul Pap, 60(10), 2584-2596. doi:10.1109/TCSI.2013.2249175.
citation: Christopher and Dana Reeve Foundation. Christopher and Dana Reeve Foundation. https://www.christopherreeve.org/. Published 2016.
citation: Technical specifications for short range devices - Issue 1 Rev 7, Apr 2013. https://www.ida.gov.sg/~/media/Files/PCDG/Licensees/StandardsQoS/RadiocomEquipStd/TSSRD.pdf
citation: Liu X, Zhou J, Wang C, et al. An Ultralow-Voltage Sensor Node Processor With Diverse Hardware Acceleration and Cognitive Sampling for Intelligent Sensing. IEEE Trans Circuits Syst II Express Briefs. 2015;62(12):1149-1153. doi:10.1109/TCSII.2015.2468927.
citation: Rebsamen B, Guan C, Zhang H, Wang C, Teo C, Ang MH Jr, Burdet E. A brain controlled wheelchair to navigate in familiar environments. IEEE Trans Neural Syst Rehabil Eng. 2010 Dec;18(6):590-8. doi: 10.1109/TNSRE.2010.2049862. Epub 2010 May 10.
citation: Rosa So, Libedinsky C, Kai Keng Ang, Wee Chiek Clement Lim, Kyaw Kyar Toe, Cuntai Guan. Adaptive decoding using local field potentials in a brain-machine interface. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:5721-5724. doi: 10.1109/EMBC.2016.7592026.
citation: So RQ, Xu Z, Libedinsky C., Ang KK, Toe KK, Yen SC, Guan CT (2015) Neural Representations of Movement during Brain-Controlled Self-Motion. Conf Proc 7th International IEEE EMBS Conference on Neural Engineering.
citation: Xu Z, Guan CT, So RQ, Ang KK, Toe KK. (2015) Motor Cortical Adaptation Induced by Closed-Loop BCI. Conf Proc 7th International IEEE EMBS Conference on Neural Engineering.
citation: Xu Z, So RQ, Toe KK, Ang KK, Guan C. On the asynchronously continuous control of mobile robot movement by motor cortical spiking activity. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:3049-52. doi: 10.1109/EMBC.2014.6944266.