- Email: [email protected]
Poster 470: Safety and Tolerability of Transcranial Direct Current Stimulation to Stroke Patients – A Phase I Current Escalation Study
S282
Abstracts / PM R 9 (2017) S131-S290
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 poststroke upper-extremity motor recovery. While this finding suggests that currents greater than the typically used 2 mA may be more efficacious, the safety and tolerability of higher currents have not been assessed in stroke patients. We aim to assess the safety and tolerability 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 stopping 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 preliminary 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 Frequency Scale (DSFS); modified Radboud Oral Motor Inventory in Parkinson’s Disease (mROMP) drooling. Safety was monitored throughout. Results: 184 subjects received treatment (75U, n¼74; 100U, n¼74; placebo, n¼36). 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 Relationships 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 physiatrist. 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
Abstracts / PM R 9 (2017) S131-S290
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 poststroke upper-extremity motor recovery. While this finding suggests that currents greater than the typically used 2 mA may be more efficacious, the safety and tolerability of higher currents have not been assessed in stroke patients. We aim to assess the safety and tolerability 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 stopping 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 preliminary 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 Frequency Scale (DSFS); modified Radboud Oral Motor Inventory in Parkinson’s Disease (mROMP) drooling. Safety was monitored throughout. Results: 184 subjects received treatment (75U, n¼74; 100U, n¼74; placebo, n¼36). 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 Relationships 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 physiatrist. 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