Trial Outcomes & Findings for Sensorimotor Imaging for Brain-Computer Interfaces (NCT NCT04723823)

NCT ID: NCT04723823

Last Updated: 2024-08-30

Results Overview

Volume of peak activity strength in sensorimotor cortex for attempted movement of right thumb (D1).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Single visit

Results posted on

2024-08-30

Participant Flow

5 individuals with spinal cord injury: recruited from University of Pittsburgh Physical Medicine \& Rehabilitation research registry. 3 individuals with amyotrophic lateral sclerosis: recruited from University of Pittsburgh/UPMC neurologist, David Lacomis, MD.

All individuals were safety screened and underwent functional magnetic resonance imaging. No individuals were excluded.

Participant milestones

Participant milestones
Measure	S1/ SCI Participants: fMRI w/ Motor or Sensory Imagery Individuals will be asked to attempt finger and hand movements while fMRI is used to measure brain activity. Motor or sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury.	M1/ ALS: fMRI w/ Motor or Sensory Imagery Individuals will be asked to attempt ankle, knee, toe, and hand movements while fMRI is used to measure brain activity. Motor or sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity.
Overall Study STARTED	5	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sensorimotor Imaging for Brain-Computer Interfaces

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Spinal Cord Injury n=5 Participants Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Sensory imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury	Participants With Amyotrophic Lateral Sclerosis n=3 Participants Individuals will be asked to imagine movements or sensations while fMRI is used to measure brain activity. Motor imagery: Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury	Total n=8 Participants Total of all reporting groups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	68.33 years n=5 Participants	26 years n=7 Participants	41.88 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Participants with movement-related brain activation	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

Volume of peak activity strength in sensorimotor cortex for attempted movement of right thumb (D1).

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Right D1 Attempt Movement Activity at S1 - SCI	893.6 mm^3 Interval 66.0 to 3355.0

PRIMARY outcome

Timeframe: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

Volume of primary activation within sensorimotor cortex for attempted movement of the right index finger (D2)

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Right D2 Attempt Movement Activity at S1 - SCI	549 mm^3 (cubic millimeters) Interval 138.0 to 1038.0

PRIMARY outcome

Timeframe: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

Volume of primary activation within sensorimotor cortex for attempted movement of the right middle finger (D3)

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Right D3 Attempt Movement Activity at S1 - SCI	391.75 mm^3 (cubic millimeters) Interval 41.0 to 790.0

PRIMARY outcome

Timeframe: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

Volume of primary activation within sensorimotor cortex for attempted movement of the right ring finger (D4)

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Right D4 Attempt Movement Activity at S1 - SCI	221.5 mm^3 (cubic millimeters) Interval 36.0 to 397.0

PRIMARY outcome

Timeframe: Single visit

Population: Individuals with hand impairment due to cervical spinal cord injury

Volume of peak activity cluster for Right hand grasp overt/attempt movement activity at S1

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at S1 - SCI	2588.8 mm^3 (cubic millimeters) Interval 1394.0 to 2799.0

PRIMARY outcome

Timeframe: Single visit

Population: Impairment of at least one arm/hand as a result of cervical spinal cord injury

Volume of peak activity cluster in M1 during overt/attempted movement of left ankle

Outcome measures

Outcome measures
Measure	Individuals With SCI n=3 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Left Ankle Overt/Attempt Movement Activity at M1 - ALS	437 mm^3 (cubic millimeters) Interval 118.0 to 936.0

PRIMARY outcome

Timeframe: Single visit

Population: Impairment of at least one arm/hand as a result of cervical spinal cord injury or amyotrophic lateral sclerosis. The ALS diagnosis should be possible, probably, or definite ALS based on El Escorial criteria.

Volume of peak activity cluster in M1 during attempted movement of right toe by individuals with ALS

Outcome measures

Outcome measures
Measure	Individuals With SCI n=3 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Right Toe Overt/Attempt Movement Activity at M1 - ALS	251.5 mm^3 (cubic millimeters) Interval 152.0 to 351.0

PRIMARY outcome

Timeframe: Single visit

Population: Impairment of at least one arm/hand as a result of cervical spinal cord injury or amyotrophic lateral sclerosis. The ALS diagnosis should be possible, probably, or definite ALS based on El Escorial criteria.

Volume of peak activity cluster in M1 during attempted right hand grasp movement by individuals with ALS

Outcome measures

Outcome measures
Measure	Individuals With SCI n=3 Participants Individuals with arm/hand impairment due to SCI
Peak Activity Volume: Right Hand Grasp Overt/Attempt Movement Activity at M1 - ALS	238.5 mm^3 (cubic millimeters) Interval 23.0 to 454.0

PRIMARY outcome

Timeframe: Single visit

Population: The x-axis coordinate is the left-to-right location of the peak activity.

This is the X-axis (right to left of head) coordinate for location of peak activity for attempted movement of right D1.

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (X-coordinate) for Right D1 Attempt Movement - SCI	176.4 mm Interval 159.0 to 183.0

PRIMARY outcome

Timeframe: Single visit

This is the Y-axis (vertical) coordinate for location of peak activity for attempted movement of right D1.

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (Y-coordinate) for Right D1 Attempt Movement - SCI	67 mm Interval 61.0 to 79.0

PRIMARY outcome

Timeframe: Single visit

This is the Z-axis (front to back of head) coordinate for location of peak activity for attempted movement of right D1.

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (Z-coordinate) for Right D1 Attempt Movement - SCI	103.2 mm Interval 95.0 to 110.0

PRIMARY outcome

Timeframe: Single visit

This is the X-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle.

Outcome measures

Outcome measures
Measure	Individuals With SCI n=3 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (X-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS	123.33 mm Interval 120.0 to 128.0

PRIMARY outcome

Timeframe: Single visit

This is the Y-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle.

Outcome measures

Outcome measures
Measure	Individuals With SCI n=3 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (Y-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS	63.67 mm Interval 60.0 to 66.0

PRIMARY outcome

Timeframe: Single visit

This is the Z-axis (right to left of head) coordinate for location of peak activity for M1 during overt/attempted movement of left ankle.

Outcome measures

Outcome measures
Measure	Individuals With SCI n=3 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (Z-coordinate) for Left Ankle Overt/Attempt Movement Activity - ALS	87.67 mm Interval 84.0 to 95.0

PRIMARY outcome

Timeframe: Single visit

Location of peak activity (X-axis coordinate): Right hand grasp overt/attempt movement activity at S1

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (X-axis): Right Hand Grasp - SCI	163.6 mm Interval 153.0 to 176.0

PRIMARY outcome

Timeframe: Single visit

Location of peak activity (Y-axis coordinate): Right hand grasp overt/attempt movement activity at S1

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (Y-axis): Right Hand Grasp - SCI	59.4 mm Interval 54.0 to 75.0

PRIMARY outcome

Timeframe: Single visit

Location of peak activity (Z-axis coordinate): Right hand grasp overt/attempt movement activity at S1

Outcome measures

Outcome measures
Measure	Individuals With SCI n=5 Participants Individuals with arm/hand impairment due to SCI
Location of Peak Activity (Z-axis): Right Hand Grasp - SCI	93 mm Interval 86.0 to 105.0

Adverse Events

Participants With Spinal Cord Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants With Amyotrophic Lateral Sclerosis

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

Debbie Harrington, CCRP

University of Pittsburgh

Phone: 412-383-1355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place