Trial Outcomes & Findings for MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury (NCT NCT02960516)

Results Overview

Michigan Hand Questionnaire assesses hand function and well being of patients with hand injuries. It is divided into 6 scales: Overall hand function, scored in a range of 5-25; Activities of daily living, scored in a range of 5-25; Work, scored in a range of 5-25; Pain, scored in a range of 5-25; Aesthetics, scored in a range of 4-16; Satisfaction, scored in a range of 6-30. For the pain scale, higher scores indicate more pain. For the other 5 scales, higher scores indicate better hand performance. These raw scores are then converted to a range of 0-100 based on the following equations: Overall hand function: -(raw score-25)/20＊100; Activities of daily living: -(raw score-25) 20＊100; Work: (raw score-5)/20＊100; Pain: If question 1=5, then pain score =0; if question 1≠5,then -(raw score-25)/20＊100; Aesthetics:(raw score-4)/16＊100; Satisfaction: -(raw score-30)/24＊100. For every patient, an overall MHQ score is obtained by summing the scores for all 6 scales and dividing by 6.

Recruitment status

COMPLETED

Target enrollment

19 participants

Primary outcome timeframe

1, 3, 4, 6, and 9 months post surgery

Results posted on

2023-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	TPNI Group Subjects who had traumatic peripheral nerve injury (TPNI)	CTS Group Participants who had carpal tunnel syndrome (CTS)	Controls Healthy control subjects
Overall Study STARTED	3	8	8
Overall Study COMPLETED	3	8	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TPNI Group n=3 Participants Subjects who had traumatic peripheral nerve injury (TPNI)	CTS Group n=8 Participants Participants who had carpal tunnel syndrome (CTS)	Controls n=8 Participants Healthy control subjects	Total n=19 Participants Total of all reporting groups
Age, Customized Age	33.3 years n=3 Participants	53.3 years n=8 Participants	32.4 years n=8 Participants	39.6 years n=19 Participants
Sex: Female, Male Female	1 Participants n=3 Participants	5 Participants n=8 Participants	7 Participants n=8 Participants	13 Participants n=19 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	6 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	23.7 kg/m^2 n=3 Participants	30.5 kg/m^2 n=8 Participants	25.7 kg/m^2 n=8 Participants	26.5 kg/m^2 n=19 Participants

PRIMARY outcome

Timeframe: 1, 3, 4, 6, and 9 months post surgery

Population: At each time point only 1 participant was assessed

Michigan Hand Questionnaire assesses hand function and well being of patients with hand injuries. It is divided into 6 scales: Overall hand function, scored in a range of 5-25; Activities of daily living, scored in a range of 5-25; Work, scored in a range of 5-25; Pain, scored in a range of 5-25; Aesthetics, scored in a range of 4-16; Satisfaction, scored in a range of 6-30. For the pain scale, higher scores indicate more pain. For the other 5 scales, higher scores indicate better hand performance. These raw scores are then converted to a range of 0-100 based on the following equations: Overall hand function: -(raw score-25)/20＊100; Activities of daily living: -(raw score-25) 20＊100; Work: (raw score-5)/20＊100; Pain: If question 1=5, then pain score =0; if question 1≠5,then -(raw score-25)/20＊100; Aesthetics:(raw score-4)/16＊100; Satisfaction: -(raw score-30)/24＊100. For every patient, an overall MHQ score is obtained by summing the scores for all 6 scales and dividing by 6.

Outcome measures

Outcome measures
Measure	Injured Hand in TPNI n=1 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the injured hand	Healthy Hand in TPNI n=1 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the healthy (un-injured) hand	Carpal Tunnel Syndrome (CTS) Subjects diagnosed with carpal tunnel syndrome	Controls Healthy subjects who did not have any nerve injury
Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery 1 month post surgery	33 score on a scale	83 score on a scale	—	—
Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery 4 months post surgery	69 score on a scale	83 score on a scale	—	—
Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery 6 months post surgery	0.8 score on a scale	81 score on a scale	—	—
Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery 9 months post surgery	6.8 score on a scale	81 score on a scale	—	—
Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery 3 months post surgery	5 score on a scale	75 score on a scale	—	—

PRIMARY outcome

Timeframe: 1, 3, 4, and 6 months post surgery

Population: The overall number of participants was 2; however at each of the time points, only 1 participant was assessed, as presented below.

The grip strength test is performed by having the participant squeeze as hard as possible on a tool known as dynamometer. Grip strength findings were compared between injured and uninjured hands in subjects with TPNI at 3,4, and 6 months post surgery. However not all participants were assessed at all time points.

Outcome measures

Outcome measures
Measure	Injured Hand in TPNI n=2 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the injured hand	Healthy Hand in TPNI n=2 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the healthy (un-injured) hand	Carpal Tunnel Syndrome (CTS) Subjects diagnosed with carpal tunnel syndrome	Controls Healthy subjects who did not have any nerve injury
Grip Strength in Subjects With TPNI Post Surgery 1 month post surgery	NA pounds Subject was not able to perform test	92 pounds	—	—
Grip Strength in Subjects With TPNI Post Surgery 3 months post surgery	30 pounds	75 pounds	—	—
Grip Strength in Subjects With TPNI Post Surgery 4 months post injury	40 pounds	100 pounds	—	—
Grip Strength in Subjects With TPNI Post Surgery 6 months post surgery	18 pounds	74 pounds	—	—

PRIMARY outcome

Timeframe: 1, 3, 4, and 6 months post surgery

Population: The overall number of participants was 2; however at each of the time points, only 1 participant was assessed, as presented below.

The Nine Hole Peg Test is used to evaluate patients' fine hand control or dexterity. The total time required to insert nine pegs into nine holes is recorded. The lower the number, the faster the time, the better the performance. 9HPT findings were compared between injured and uninjured hand at 3,4, and 6 months post surgery in subjects with TPNI. However not all participants were assessed at all time points.

Outcome measures

Outcome measures
Measure	Injured Hand in TPNI n=2 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the injured hand	Healthy Hand in TPNI n=2 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the healthy (un-injured) hand	Carpal Tunnel Syndrome (CTS) Subjects diagnosed with carpal tunnel syndrome	Controls Healthy subjects who did not have any nerve injury
9 Hole Peg Test in Subjects With TPNI 6 months post surgery	51 seconds	26 seconds	—	—
9 Hole Peg Test in Subjects With TPNI 1 month post surgery	NA seconds Subject was unable to perform test	23 seconds	—	—
9 Hole Peg Test in Subjects With TPNI 3 months post surgery	43 seconds	27 seconds	—	—
9 Hole Peg Test in Subjects With TPNI 4 months post surgery	100 seconds	27 seconds	—	—

PRIMARY outcome

Timeframe: Subjects with TPNI underwent imaging at time points falling between 1 and 9 months post surgery. Subjects with CTS underwent imaging at time points falling between 1 and 24 months post surgery.

Subjects underwent DTI at different time points post surgery; and the metrics analyzed were: Mean Diffusivity (MD), Axial Diffusivity (AD), and Radial Diffusivity (RD). Imaging was done to the "healthy" median nerve in controls, injured and healthy (median or ulnar) nerves in patients with TPNI, and compressed median nerve in patients with Carpal Tunnel Syndrome (CTS). Imaging was done at multiple timepoints post surgery. Subjects with TPNI underwent imaging at time points falling between 1 and 9 months post surgery. Subjects with CTS underwent imaging at time points falling between 1 and 24 months post surgery. The values were then averaged for each group, as presented below.

Outcome measures

Outcome measures
Measure	Injured Hand in TPNI n=3 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the injured hand	Healthy Hand in TPNI n=3 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the healthy (un-injured) hand	Carpal Tunnel Syndrome (CTS) n=8 Participants Subjects diagnosed with carpal tunnel syndrome	Controls n=8 Participants Healthy subjects who did not have any nerve injury
Diffusion Tensor Imaging (DTI) Diffusivity Metrics Post Surgery Mean Diffusivity (MD)	1.41 μm^2/ms Standard Deviation 0.15	1.13 μm^2/ms Standard Deviation 0.28	1.27 μm^2/ms Standard Deviation 0.06	1.09 μm^2/ms Standard Deviation 0.05
Diffusion Tensor Imaging (DTI) Diffusivity Metrics Post Surgery Axial Diffusivity (AD)	1.91 μm^2/ms Standard Deviation 0.19	1.82 μm^2/ms Standard Deviation 0.42	1.90 μm^2/ms Standard Deviation 0.06	1.92 μm^2/ms Standard Deviation 0.05
Diffusion Tensor Imaging (DTI) Diffusivity Metrics Post Surgery Radial Diffusivity (RD)	1.16 μm^2/ms Standard Deviation 0.15	0.78 μm^2/ms Standard Deviation 0.25	1.01 μm^2/ms Standard Deviation 0.06	0.67 μm^2/ms Standard Deviation 0.05

PRIMARY outcome

Timeframe: Subjects with TPNI underwent imaging at time points falling between 1 and 9 months post surgery. Subjects with CTS underwent imaging at time points falling between 1 and 24 months post surgery.

Subjects underwent DTI at different time points post surgery and the metric Fractional anisotropy (FA) was analyzed. FA is a scalar value between 0-1 that describe anisotropy of a diffusion process. A value of zero means that diffusion is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. Imaging was done to the "healthy" median nerve in controls, injured and healthy (median or ulnar) nerves in patients with TPNI, and compressed median nerve in patients with Carpal Tunnel Syndrome (CTS). Imaging was done at multiple timepoints post surgery.

Outcome measures

Outcome measures
Measure	Injured Hand in TPNI n=3 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the injured hand	Healthy Hand in TPNI n=3 Participants Subjects who had traumatic peripheral nerve injury (TPNI), with the assessment being done on the healthy (un-injured) hand	Carpal Tunnel Syndrome (CTS) n=8 Participants Subjects diagnosed with carpal tunnel syndrome	Controls n=8 Participants Healthy subjects who did not have any nerve injury
Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Metric Post Surgery	0.32 score on a scale Standard Deviation 0.06	0.48 score on a scale Standard Deviation 0.14	0.43 score on a scale Standard Deviation 0.03	0.59 score on a scale Standard Deviation 0.03

Adverse Events

TPNI Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CTS Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

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. Wesley Thayer

Vanderbilt university medical center

Phone: +1 (615)936-3759

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place