Trial Outcomes & Findings for Neuromodulation in Lower Limb Amputees (NCT NCT04543786)

Last Updated: 2023-07-24

Results Overview

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Day 2

Results posted on

2023-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Transcutaneous Spinal Cord Stimulation Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuromodulation in Lower Limb Amputees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Man	2 Participants n=5 Participants
Sex/Gender, Customized Gender · Woman	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
H-reflex threshold	NA mA STANDARD_DEVIATION NA • n=5 Participants
PRM threshold	59.5 mA STANDARD_DEVIATION 6.1 • n=5 Participants
Phantom limb pain score	34 Score on a Scale STANDARD_DEVIATION 7 • n=5 Participants
Pain pressure threshold	23.84 Newton STANDARD_DEVIATION 13.08 • n=5 Participants
Pain score	6 Score on a Scale STANDARD_DEVIATION 2 • n=5 Participants
Side of limb amputation Left	2 Participants n=5 Participants
Side of limb amputation Right	1 Participants n=5 Participants
Nature of limb amputation Trauma	1 Participants n=5 Participants
Nature of limb amputation Diabetic Neuropathy	1 Participants n=5 Participants
Nature of limb amputation Alcohol Neuropathy	1 Participants n=5 Participants
Time since amputation < 6 months	1 Participants n=5 Participants
Time since amputation >= 5 years	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean H-reflex Threshold	NA mA Standard Deviation NA H-reflexes could not be evoked in any of the participants

PRIMARY outcome

Timeframe: Day 3

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean H-reflex Threshold	NA mA Standard Deviation NA H-reflexes could not be evoked in any of the participants

PRIMARY outcome

Timeframe: Day 4

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean H-reflex Threshold	NA mA Standard Deviation NA H-reflexes could not be evoked in any of the participants

PRIMARY outcome

Timeframe: Day 5

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean H-reflex Threshold	NA mA Standard Deviation NA H-reflexes could not be evoked in any of the participants

PRIMARY outcome

Timeframe: Day 2

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean PRM Reflex Threshold	56.7 mA Standard Deviation 4.9

PRIMARY outcome

Timeframe: Day 3

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean PRM Reflex Threshold	55.8 mA Standard Deviation 5.9

PRIMARY outcome

Timeframe: Day 4

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean PRM Reflex Threshold	56.2 mA Standard Deviation 7.6

PRIMARY outcome

Timeframe: Day 5

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Mean PRM Reflex Threshold	38.6 mA Standard Deviation 12.2

SECONDARY outcome

Timeframe: Day 5

McGill Pain Questionnaire: minimum = 0, maximum = 78, the higher the pain score the greater the pain

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Phantom Limb Pain Score	18.3 Score on a Scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: Day 5

Population: One participant excluded from this analysis due to inconsistent pain medication use on last testing day

Pain Pressure Threshold Test using an algometer: minimum force that induces pain, minimum = 0 N, maximum = 444.8 N, a lower threshold indicates hypersensitivity

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=2 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Pain Pressure Threshold	50.67 Newton Standard Deviation 26.07

SECONDARY outcome

Timeframe: Day 2

Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Pain Score	4.7 Score on a Scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Day 3

Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Pain Score	3.7 Score on a Scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Day 4

Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Pain Score	4.8 Score on a Scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day 5

Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain

Outcome measures

Outcome measures
Measure	Transcutaneous Spinal Cord Stimulation n=3 Participants Transcutaneous spinal cord stimulation: Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
Pain Score	4.5 Score on a Scale Standard Deviation 0.5

Adverse Events

Transcutaneous Spinal Cord Stimulation

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

Lee Fisher

University of Pittsburgh

Phone: 412-383-1329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place