- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811301
[BrainConnexion] - Neurodevice Phase I Trial
May 4, 2023 updated by: National Neuroscience Institute
Neurodevice Phase I: Wireless Implantable Neurodevice Microsystem for Neuroprosthesis and Neuroscience
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 308433
- National Neuroscience Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 21 years old and older
- Tetraparesis
- 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.
- Able to perform the pre-operation Brain Computer Interface training as judged by the research team.
Exclusion Criteria:
- Significant medical co-morbidities e.g. cardiac disease
- Bleeding disorders
- Any contraindication to surgery
- Other concomitant intracranial pathologies
- History of seizures or epilepsy disorder
- Complications of coagulopathy
- Surgically unfit
- Significant psychological issues e.g. Depression
- Poor psychological support
- Pregnancy
- No means of communication
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Interventional
Wireless Implantable Neurodevice Microsystem
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A 4.4mm by 4.2mm electrode array is placed onto the surface of the motor cortex which is then connected to a miniaturized neural recording microsystem that transmits signals wirelessly to control an external assistive device.
Neural signals are recorded at least once every week for 12 months or longer.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation.
Time Frame: 6 months post-implant
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The primary objective of this study is to determine the safety of the device.
This will be assessed based on the number of SAEs and AEs reported for each patient during the 12 months post-implantation evaluation.
This measure will considered a success if the device is not removed for safety reasons within 12-months after implantation.
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6 months post-implant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The signal quality of the electrodes for long-term recording of neural signals.
Time Frame: Day 1 to Day 365 post-implant
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Signal quality will be measured by the number of channels with identifiable single units tracked across each day for 12 months.
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Day 1 to Day 365 post-implant
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Decoding accuracy per training session.
Time Frame: Day 1 to Day 365 post-implant
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Decoding accuracy will be measured in percentage (%).
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Day 1 to Day 365 post-implant
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Number of successful trials per session
Time Frame: Day 1 to Day 365 post-implant
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The number of successful trials per training session will be measured in percentage (%).
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Day 1 to Day 365 post-implant
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Time taken to complete each trial per session
Time Frame: Day 1 to Day 365 post-implant
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This will be measured in seconds (s).
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Day 1 to Day 365 post-implant
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Christopher and Dana Reeve Foundation. Christopher and Dana Reeve Foundation. https://www.christopherreeve.org/. Published 2016.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2017
Primary Completion (Actual)
January 27, 2023
Study Completion (Anticipated)
August 27, 2023
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
January 17, 2019
First Posted (Actual)
January 22, 2019
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Muscular Disorders, Atrophic
- Paralysis
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Muscular Dystrophies
- Spinal Cord Injuries
- Quadriplegia
- Locked-In Syndrome
Other Study ID Numbers
- BrainConnexion
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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