NCT01364480

Microelectrode Brain-Machine Interface for Individuals With Tetraplegia

Terminated NA Results posted Last updated 9 January 2024

What this trial tests

NA trial testing Implantation of NeuroPort Arrays in the motor cortex in Tetraplegia in 1 participant. Terminated before completion.

Timeline

1 May 2011

Primary endpoint
26 November 2022

26 November 2022

Quick facts

Lead sponsor	Michael Boninger
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	1
Start date	1 May 2011
Primary completion	26 November 2022
Estimated completion	26 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Implantation of NeuroPort Arrays in the motor cortex

Conditions studied

• Tetraplegia — all drugs for Tetraplegia →
• Spinal Cord Injury — all drugs for Spinal Cord Injury →

Sponsor

Michael Boninger

Who can join

Adults 18 to 70, any sex, with Tetraplegia or Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Successful Implant Primary · One year following array implantation

Number of participants who were implanted for at least one year without having to explant the device for safety reasons.

Group	Value	95% CI
Brain-Machine Interface Users	1

7 Degree-of-freedom Movement by Neural Control Secondary · One year following array implantation

A modified Action Research Arm Test (ARAT) assessment for upper extremity performance was conducted to evaluate neural control of movement of a robotic prosthetic arm with 7 independent degrees of freedom controlled simultaneously. The degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 1D open/closing of hand. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Each test item was timed and scored as 0 (no movement), 1 (task partly done), 2 (task done, but not correctly), or 3 (task done correctly). Movements that required more than 5 s

Group	Value	95% CI
Brain-Machine Interface Users	16

10 Degree-of-freedom Movement by Neural Control Secondary · One year following array implantation

A modified ARAT was conducted to assess neural control of movement of a robotic prosthetic arm with 10 independent degrees of freedom, controlled simultaneously. Degrees of freedom included: 3D translation of arm, 3D orientation of wrist, and 4 degrees dictating hand shape, including pinch (flexion of thumb, index and middle fingers), scoop (flexion of ring and pinky fingers), finger abduction (of index, ring and little fingers), and thumb opposition. The participant used a brain-controlled robotic hand to do 9 tasks (out of 19). Test items were timed and scored as 0 (no movement), 1 (task par

Group	Value	95% CI
Brain-Machine Interface Users	15.6

Adverse events — posted to ClinicalTrials.gov

Time frame: through study completion, 2 years, 8.5 months duration of implant. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brain-Machine Interface Users

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (1 terms — click to expand)

Reaction	System	Brain-Machine Interface Us…
Skin retraction at pedestal site	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT01364480 adverse events section.

Sponsor's own description

The purpose of this research study is to demonstrate the safety and efficacy of using two NeuroPort Arrays (electrodes) for long-term recording of brain activity.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-performance neuroprosthetic control by an individual with tetraplegia.
   Collinger JL, Wodlinger B, Downey JE, Wang W, et al · · 2013 · cited 1098× · PMID 23253623 · DOI 10.1016/s0140-6736(12)61816-9
2. Ten-dimensional anthropomorphic arm control in a human brain-machine interface: difficulties, solutions, and limitations.
   Wodlinger B, Downey JE, Tyler-Kabara EC, Schwartz AB, et al · · 2015 · cited 338× · PMID 25514320 · DOI 10.1088/1741-2560/12/1/016011
3. Explant Analysis of Utah Electrode Arrays Implanted in Human Cortex for Brain-Computer-Interfaces.
   Woeppel K, Hughes C, Herrera AJ, Eles JR, et al · · 2021 · cited 65× · PMID 34950640 · DOI 10.3389/fbioe.2021.759711
4. Blending of brain-machine interface and vision-guided autonomous robotics improves neuroprosthetic arm performance during grasping.
   Downey JE, Weiss JM, Muelling K, Venkatraman A, et al · · 2016 · cited 62× · PMID 26987662 · DOI 10.1186/s12984-016-0134-9
5. Collaborative approach in the development of high-performance brain-computer interfaces for a neuroprosthetic arm: translation from animal models to human control.
   Collinger JL, Kryger MA, Barbara R, Betler T, et al · · 2014 · cited 48× · PMID 24528900 · DOI 10.1111/cts.12086
6. Longevity and reliability of chronic unit recordings using the Utah, intracortical multi-electrode arrays.
   Sponheim C, Papadourakis V, Collinger JL, Downey J, et al · · 2021 · cited 44× · PMID 34847547 · DOI 10.1088/1741-2552/ac3eaf
7. Motor cortical activity changes during neuroprosthetic-controlled object interaction.
   Downey JE, Brane L, Gaunt RA, Tyler-Kabara EC, et al · · 2017 · cited 44× · PMID 29209023 · DOI 10.1038/s41598-017-17222-3
8. Brain-Computer Interfaces in Neurorecovery and Neurorehabilitation.
   Young MJ, Lin DJ, Hochberg LR. · · 2021 · cited 35× · PMID 33742433 · DOI 10.1055/s-0041-1725137