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TBI, especially those with seemingly mild TBI, for PTHs in order to
offer treatment sooner and prevent adverse effects on veterans’
daily lives.
Level of Evidence:
Level IV
CATEGORY: NEUROLOGICAL REHABILITATION
Poster 470:
Safety and Tolerability of Transcranial Direct
Current Stimulation to Stroke Patients
e
A Phase I Current
Escalation Study
Wuwei Feng, MD MS (Medical University of South Carolina,
Charleston, SC, United States), Pratik Y. Chhatbar, MD PhD,
Steven A. Kautz, PhD, Mark George, MD
Disclosures:
Wuwei Feng: I Have No Relevant Financial Relationships
To Disclose
Objective:
A prior meta-analysis revealed that higher doses of
transcranial direct current stimulation (tDCS) have a better post-
stroke upper-extremity motor recovery. While this finding suggests
that currents greater than the typically used 2 mA may be more effi-
cacious, the safety and tolerability of higher currents have not been
assessed in stroke patients. We aim to assess the safety and tolera-
bility of single session of up to 4 mA in stroke patients.
Design:
We adapted a traditional 3 + 3 study design with a current
escalation schedule of 1
>
2
>
2.5
>
3
>
3.5
>
4 mA for this tDCS safety and
tolerability study.
Setting:
Stroke rehabilitation center
Participants:
First-ever ischemic stroke patients with unilateral motor
impairment with Fugl-Meyer upper extremity scale score
<
¼
56/66.
Interventions:
We administered one 30-min session of bihemispheric
montage tDCS and simultaneous customary occupational therapy to
patients with first-ever ischemic stroke.
Main Outcome Measures:
We assessed safety with pre-defined stop-
ping rules (second degree skin burn, clinical seizure; ADC abnormality
or discontinuation from the study) and investigated tolerability
through a questionnaire.
Results:
18 patients completed the study. The current was escalated to
4 mA without meeting the pre-defined stopping rules or causing any
major safety concern. 50% of patients experienced transient skin
redness without injury. No rise in temperature (range 26-35 C) was noted
and skin barrier function remained intact (i.e. body resistance
>
1KM).
Conclusions:
Our phase I safety study supports that single session of
bihemispheric tDCS with current up to 4 mA is safe and tolerable in
stroke patients. A phase II study to further test the safety and pre-
liminary efficacy with multi-session tDCS at 4 mA (as compared with
lower current and sham stimulation) is a logical next step.
ClinicalTrials.gov Identifier: NCT02763826.
Level of Evidence:
Level I
CATEGORY: NEUROLOGICAL REHABILITATION
Poster 471:
SIAXI: Efficacy and Safety of IncobotulinumtoxinA
for the Treatment of Sialorrhea in Parkinson’s Disease (PD),
Stroke, and Other Neurological Conditions: Results of a Phase III,
Placebo-Controlled, Randomized, Double-Blind Study
Andrew Blitzer, MD (Columbia University, New York, NY, United
States), Andrzej Friedman, MD, Olaf Michel, MD, Birgit Flatau-Baque´,
MD, Ja´nos Csiko´s, MD, Wolfgang Jost, MD
Disclosures:
Andrew Blitzer: Research Grants - Merz
Objective:
To examine the safety and efficacy of incobotulinumtoxinA
in the treatment of sialorrhea due to PD and other etiologies.
Design:
Prospective, randomized, double-blind, placebo-controlled,
parallel-group study.
Setting:
33 European sites.
Participants:
Adults with chronic, troublesome sialorrhea due to
Parkinson’s disease (PD), stroke, and other etiologies.
Interventions:
75U or 100U incobotulinumtoxinA, or placebo. For the
higher/lower dose groups, 15U/20U of incobotulinumtoxinA were
injected into each submandibular gland, and 22.5U/30U into each
parotid gland.
Main Outcome Measures:
Co-primary outcomes: Unstimulated Salivary
Flow Rate (uSFR) at week 4 vs baseline and Global Impression of Change
Scale (GICS) at week 4. Secondary outcomes: Drooling Severity and Fre-
quency Scale (DSFS); modified Radboud Oral Motor Inventory in Parkin-
son’s Disease (mROMP) drooling. Safety was monitored throughout.
Results:
184 subjects received treatment (75U, n
¼
74; 100U, n
¼
74;
placebo, n
¼
36). Sialorrhea etiologies: PD (70.6%), atypical Parkinson
syndromes (8.7%), stroke (17.9%), traumatic brain injury (2.7%). The
100U group showed -0.13 g/min (SE 0.026, 95% CI) LS-mean uSFR
reduction and +1.25 points (SE 0.144, 95% CI) LS-mean improvement on
GICS at week 4 compared with baseline. Both coprimary outcomes were
significantly greater in the 100U dose group vs placebo at week 4
(P
<
.005). The 75U dose was numerically more effective than placebo at
week 4 but did not reach statistical significance. Improvements in uSFR
and GICS at weeks 8 and 12 were observed in both incobotulinumtoxinA
groups, with improvement in the uSFR maintained at week 16. DSFS and
mROMP drooling assessments supported the effectiveness of both
doses. The safety and tolerability profile was favorable; no new or
unexpected safety signals were identified.
Conclusions:
Doses of 75U and 100U incobotulinumtoxinA are
effective up to 16 weeks for treatment of sialorrhea in PD and
other neurological conditions; greater improvement was observed
for the 100U treatment without meaningful added risks for adverse
effects.
Level of Evidence:
Level I
CATEGORY: QUALITY IMPROVEMENT
Poster 472:
Improving Breadth, Depth, and Outcomes of
Medical Rehabilitation after Level One Trauma Care
Daniela A. Iliescu, Medical Student (Creighton University School of
Medicine, Omaha, Nebraska, United States), Karl J. Sandin, MD, MPH
Disclosures:
Daniela Iliescu: I Have No Relevant Financial Relation-
ships To Disclose
Objective:
To define interventions associated with better access to
and better outcomes of medical rehabilitation after trauma.
Design:
Before and after non-experimental trial with 12-month
follow-up.
Setting:
Academic Trauma Center and Associated Rehabilitation Unit.
Participants:
56 Trauma patients admitted over 2-year period to
rehabilitation.
Interventions:
1. Twice weekly participation by consultation/liaison
physiatrist in trauma pass-on teaching rounds. 2. Participation by
physiatrist and rehabilitation admissions coordinator, in weekly trauma
discharge planning conference. 3. Monthly presentation by physiatrist
at formal trauma quality improvement committee. 4. Continued
training of admissions coordinator in trauma rehabilitation by phys-
iatrist. 5. Week-daily availability of physiatrist for formal acute care
consultation.
Main Outcome Measures:
Number of patients admitted from level one
trauma to inpatient acute medical rehabilitation; rehabilitation
impairment group codes of those admitted patients; mean Functional
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Abstracts / PM R 9 (2017) S131-S290