Trial Outcomes & Findings for Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia (NCT NCT01849822)

Last Updated: 2021-04-30

Results Overview

The primary effectiveness objective of this study is to evaluate the effectiveness of the NPS in controlling virtual or physical end effectors. The driving hypotheses are that control over the physical and virtual end effectors, as measured by accuracy, will be significantly greater than the level of chance. Three methods will be used to assess the effectiveness of the extracorporeal device: standardized tests, comparison of task performance to the level of chance, and the Quality-of-Life Inventory (QOLI). In collaboration with therapists at Rancho Los Amigos National Rehabilitation Center, two commonly-used, standard tests have been selected by which the use of robotic arm will be evaluated: the Action Research Arm Test (ARAT) and the Canadian Occupational Performance Measure (COPM).

Recruitment status

COMPLETED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

Six years after array implantation

Results posted on

2021-04-30

Participant Flow

The enrolled subject was recruited through Rancho Los Amigos Rehabilitation Center by the study medical investigator.

Participant milestones

Participant milestones
Measure	Neural Prosthetic System The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neural Prosthetic System n=1 Participants The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants
Patient Control Over the End Effector (Virtual or Physical)	1 Participants n=93 Participants
Absence of Infection or Irritation	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Six years after array implantation

Population: tetraplegic patient

Outcome measures

Outcome measures
Measure	Neural Prosthetic System n=1 Participants The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
Number of Participants With Patient Control Over the End Effector (Virtual or Physical)	1 Participants

PRIMARY outcome

Timeframe: Six years after array implantation

Population: Tetraplegic patient

The primary objective of this study is to evaluate the safety of the NPS. The driving hypotheses are that the implantation will not be associated with infection or irritation, and that the serious adverse event rate will not rise above 1%. The method of evaluation will be inspection of subject's scalp for evidence of reddening or discharge; review of new symptoms including possible fever, headache, visual or auditory changes, or change in mood or behavior; serial neurologic exams. The condition of the area will be compared with its condition on previous visits. History will be obtained regarding new symptoms. Neurologic exam will be compared to baseline neuro exam. The SAE rate will be calculated as the number of SAEs per implant days.

Outcome measures

Outcome measures
Measure	Neural Prosthetic System n=1 Participants The Neural Prosthetic System consists of two Neuroport Arrays. Both Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subjects will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought. They will then use the end effector to perform various reach and grasp tasks.
Number of Participants With Absence of Infection or Irritation	1 Participants

Adverse Events

Neural Prosthetic System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Richard Andersen

California Institute of Technology

Phone: 16263958336

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place