This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jennifer Collinger, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01393444
First received: July 11, 2011
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: August 17, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions: Tetraplegia
Spinal Cord Injury
Brachial Plexus Injury
Muscular Dystrophy
ALS
Brainstem Stroke
Intervention: Device: Implantation of ECoG sensors on the brain surface

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment included interfacing with local research registry participants, clinical SCI physicians, MDS and ALS groups, and attending conferences attended by eligibility populations

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study did not include "arms" or group assignments.

Reporting Groups
  Description
Direct Brain Interface Users

All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms.

Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants


Participant Flow:   Overall Study
    Direct Brain Interface Users
STARTED   6 
First (1st Implanted) Subject Enrolled   1 [1] 
Second Subject Enrolled   1 [2] 
Third Subject Enrolled   1 [3] 
Fourth Subject Enrolled   1 [4] 
Fifth (2nd Implanted) Subject Enrolled   1 [5] 
Sixth (3rd Implanted) Subject   1 [6] 
COMPLETED   3 [7] 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Determined ineligible during screening.                2 
[1] 2011: Individual with cervical spinal cord injury enrolled and was eligible. Implanted in 2011.
[2] 2012: Second participant enrolled. Ineligible.
[3] 2013: Third participant enrolled. Withdrew due to family commitments.
[4] 2013: Fourth participant enrolled. Ineligible.
[5] 2013: Individual with ALS enrolled and was eligible. Implanted in 2014.
[6] 2014: Individual with brachial plexus injury enrolled and was eligible. Implanted in 2015.
[7] 2015: Third implanted subject completed the study. This fulfilled the requirements of our grant.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All individuals were English speaking, with a disability of at least one hand/arm, but no other health issues which would interfere with or be made worse by study participation.

Reporting Groups
  Description
Direct Brain Interface Users

All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms.

Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants


Baseline Measures
   Direct Brain Interface Users 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   0 
Age 
[Units: Years]
Mean (Full Range)
 39 
 (20 to 54) 
Gender 
[Units: Participants]
 
Female   1 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG   [ Time Frame: Up to 29 days of device implantation ]

2.  Secondary:   Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System   [ Time Frame: Up to 29 days of device implantation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Collinger
Organization: University of Pittsburgh
phone: 412-383-1274
e-mail: collingr@pitt.edu



Responsible Party: Jennifer Collinger, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01393444     History of Changes
Other Study ID Numbers: PRO10010149
Study First Received: July 11, 2011
Results First Received: August 17, 2016
Last Updated: October 18, 2016