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TetraplegiaNCT03811301

[BrainConnexion] - Neurodevice Phase I Trial

A study testing BrainConnexion in people with Tetraplegia and Tetraplegia/Tetraparesis, run by National Neuroscience Institute at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
BrainConnexion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteSingapore
Study dates
21 Nov 2017to 27 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Neuroscience Institute

    Singapore, 308433

Other trials in Singapore

About this study

Official title: 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.

Read the 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.

Being tested
BrainConnexion
Medical subject headings
Quadriplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Locked-In Syndrome, Muscular Dystrophies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrainConnexionDevice

    Also called Neurodevice, NeuroPort

    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.

Study groups in NCT03811301
Study groupRoleWhat they receive
InterventionalExperimentalWireless Implantable Neurodevice Microsystem
Receives: Device: BrainConnexion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation.

    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.

    Measured: 6 months post-implant

Secondary outcomes (4)

  1. The signal quality of the electrodes for long-term recording of neural signals.

    Signal quality will be measured by the number of channels with identifiable single units tracked across each day for 12 months.

    Measured: Day 1 to Day 365 post-implant

  2. Decoding accuracy per training session.

    Decoding accuracy will be measured in percentage (%).

    Measured: Day 1 to Day 365 post-implant

  3. Number of successful trials per session

    The number of successful trials per training session will be measured in percentage (%).

    Measured: Day 1 to Day 365 post-implant

  4. Time taken to complete each trial per session

    This will be measured in seconds (s).

    Measured: Day 1 to Day 365 post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2019
  2. Study start21 Nov 2017
  3. Primary completion27 Jan 2023
  4. Study completion27 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811301
Sponsor's protocol ID
BrainConnexion
Status last verified
Nov 2022
First submitted
17 Dec 2018
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27802344

  • 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.

    PubMed 16838014

  • 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.

    PubMed 22596161

  • 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.

    PubMed 23253623

  • 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.

    PubMed 25999506

  • 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.

    PubMed 24776634

  • 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.

    PubMed 25482026

  • 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.

    PubMed 17041833

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing BrainConnexion in people with Tetraplegia and Tetraplegia/Tetraparesis, run by National Neuroscience Institute at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of serious adverse events (SAEs) and adverse events (AEs) reported per patient 12 months post-implantation. (time frame: 6 months post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03811301, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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