Stimulation Treatment Philip Lavin PhD FASA FRAPS Wolfgang Schaden MD f or Tissue Regeneration Technologies LLC 1 Patient n10 Characteristics Gender 6M 4F Age range 1773 years ID: 804698
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Slide1
Project Walk Atlanta:Spinal Cord InjuryStimulation Treatment
Philip Lavin, PhD, FASA, FRAPSWolfgang Schaden MD forTissue Regeneration Technologies LLC
1
Slide2Patient (n=10) Characteristics
Gender: 6M, 4FAge range: 17-73 yearsTSI range: 14-112 monthsInjury Sites: C3, C5, C6(2), C7, T3(3), T4, T10Laminectomy: 9N, 1YASIA Score: 6A, 4BPara/Quad: 6P, 4Q
Injury:
6 Complete, 4 Incomplete
Injury type:
5 moving vehicles2 gunshots1 diving1 post-surgical1 pedestrianLesion type:3 bruised3 squeezed/crushed2 ruptured1 compression fracture1 unknown
2
Slide3Treatment HistoryTRT stimulation completed: 10/10
Time treated range: 7-39 wks (median 12.5 wks)# TRT treatments:5-17 (median 10)Total shocks (x1000):
21.75-72 (median 42.45)
Highest energy (
mJ
/m2):0.13-0.23 (median 0.14)All study therapy completed as plannedOther therapies: 4/101 hyperbaric and IMT1 hyperbaric1 rehabilitation1 stem cellsPhysical therapy:4-40
hrs
(median 29
hrs
)
3
Slide4Project Walk Metric Improvement
Significant mean improvements (two-sided p=0.004, sign test) relative to baseline
#
Baseline
Exit
ChangeTSI (m), LesionInjury SiteInjury Type
1
3
10.5
+7.5
83, Ruptured
C5
Q, Complete
21216+427, BruisedT3P, Complete3716+915. ThermalT3P, Incomplete413NANA93, BruisedT10P, Complete546+2112, CrushedC3Q, Incomplete61618+238, Comp FxC6Q, Incomplete71316+327, RupturedC6Q, Complete81620+466, SqueezedT3P, Incomplete91114+333, BruisedC7P, Complete101317+414, CrushedT4P, Complete
4
Slide5Efficacy ScoringNA: Not applicable-2: Much worse relative to baseline
-1: Worse relative to baseline0: Same as baseline+1: Better than baseline+2: Much better than baseline+3: Returned to normal5
Slide6Efficacy MeasuresSpasticity
Core StrengthCore MovementCore SensitivityLeg Muscle MassLeg Extremity StrengthLeg Extremity MovementLeg Extremity SensitivityLeg Extremity Reflexes
Bladder Function
Bowel Function
Sexual Function
Lung and DiaphramPerspiration below injurySensitivity to coldNerve painWounds (not included)Scar appearanceChronic ulcers
6
Slide7Case Specific Best Improvements
Multi-dimensional improvements for all cases
#
Best 1
st
Best 2ndBest 3rdTSI (m), LesionInjury Type
1
Lung/
Diaph
+3
6 of 15 others +2
83, Rupture
Q, Complete
2Core Str +2Core Mov +23 others +227, BruisedP, Complete3Leg Ex Se +28 of 14 others +115. MissingP, Incomplete4Spasticity +2Leg Ex Mv +2Leg Ex R +293, BruisedP, Complete58 of 15 measures +1 112, CrushedQ, Incomplete6Core Mov +26 of 14 others +138, Comp FxQ, Incomplete78 of 15 measures +1 27, RuptureQ, Complete86 of 14 measures +166, SqueezedP, Incomplete92 of 16 measures +133, BruisedP, Complete10Lung/Diaph
+3
Core S/M +2
All 5 Leg +2
14, Crushed
P, Complete
7
Slide8Degree of Improvement (1)
Efficacy Measure+3
+2
+1
0
Spasticity (2 rated -1)0133Core Strength
0
3
5
2
Core Movement
0
4
33Core Sensitivity0082Leg Muscle Mass0226Leg Extremity Strength0253Leg Extremity Movement0343Leg Extremity Sensitivity0244Leg Extremity Reflexes02538
Slide9Degree of Improvement (2)
Efficacy Measure+3
+2
+1
0
Bladder Function0019Bowel Function
0
0
0
10
Sexual Function
0
1
09Lung and Diaphram (4 NA)2022Perspiration below injury0343Sensitivity to cold0154Nerve Pain (1 rated -1)00169
Slide10Best Overall Improvement (3)
Efficacy Measure+3
+2
+1
0
Spasticity (2 rated -1)0133Best Core Measure
0
4
6
0
Best Leg Measure
0
4
60Best Function Measure0118Lung and Diaphram (4 NA)2022Perspiration below injury0343Best Sensory Measure0352Best Overall244010
Slide11Mean # Measures Improving Per CaseMultidimensional benefits as shown below:
Measure Score
Total Cases With At Least One Such Score
Total # Measures With That Score
Overall Average
Per 10 Cases+32 2
0.2
+2
6
24
2.4
+1
10
525.2010727.2-1230.311
Slide12Overall Efficacy Results ConfidenceAll patients experienced improvements
Lower 95% confidence bounds beyond chance
Best Outcome
Percent Achieving
95% Lower Bound
+320%5.1%+2 or +360%33.6%
+1 or +2 or +3
100%
74.1%
12
Slide13Patient Self Assessment (1-10)1 = baseline with 10 = total recovery
Favorable self-perception of improvement
Rating
Percent Achieving
95% Lower Bound
At least 2100%74.1%At least 390%65.0%
At least 4
60%
33.6%
At least 5
50%
25.1%
At least 6
20%5.1%At least 710%1.0%13
Slide14Correlations14
0.86 Correlation Coefficien
t
Slide15Correlations15
0.79 Correlation Coefficient
Slide16Correlations16
0.90 Correlation Coefficient
Slide17Correlations
Correlation
Patient/Therapist Survey: % Improvement
DAS
Evaluation: % Improvement from baseline to
NormalProject Walk Baseline DAS Score Improvement %
Patient Self
Assessment
:
%
Improvement to normal
Correl. to hrs. of Therapy
0.18
-0.190.030.00Correl. to # of treatments0.900.270.220.47Correl. to # of shock0.790.060.020.36Correl. to wks. in study0.470.480.860.6517Number of treatments, & more importantly, weeks since 1st treatment are most significant factors for measurable improvements.
Slide18DATA18
MIN
MAX
Median
Mean
Number of weeks in
Study
7
39
13
14
Number of Treatments
5
171011Total # of Shocks21750720004245046000Highest energy (mj/mm ^2)0.130.230.140.17Hours of Therapy during study4402926Final Project Walk evaluation6201615Median & Mean were similar for data setsM
ost patients
received
low
energy
shocks
Slide19What We Can Take from the Data# of treatments, # of shocks, & weeks in study: Positive
correlation for assessmentsWhile relatively similar numbers of each for each patient, the small differences were keyTime since first treatment was most importantPositive correlation of at least 0.47 for weeks in study, with independent evaluation = 0.86
19
Slide20Wound AssessmentsWound healing was also observed for all wounds
Chronic ulcers healed for all 3 patients with chronic ulcers at baselineScar appearance improved for all 7 patients with scars; the other 3 patients did not have scarsmuch better (+2) for 2 patientsimproved (+1) for 5 patients
20
Slide21Safety1 case (#3) had small bruises on their foot which was classified as mild and resolved
No cases had any distal adverse events21
Slide22Moving Forward
All experienced improvement from baselineMean number of improvements: 0.2 resolved, 2.4 much better, and 5.2 improved => 7.8 per caseMulti-dimensional treatment benefit20% +3, 60% +2, and 100% +1 relative to baseline4 of 6 completes and 2 of 4 incompletes experienced +2 or +3 Project Walk metric confirmation
Patient self assessment confirmation
No safety issues
All willing to continue treatment
22
Slide23The End
23
Slide24DATA
MIN
MAX
Median
Mean
Patient/Therapist: % Improvement
4%
42%
20%
22%
Independent:
%
Improvement
5%23%10%11%Project Walk Improvement %13%250%31%65%Patient Self Assessment20%70%45%43%24The Median & Mean were equivalent for virtually all forms of assessmentWhile treatments were relatively similar for each patient, all saw an improvement!