Trial Outcomes & Findings for Fostering Eating After Stroke With Transcranial Direct Current Stimulation (NCT NCT01919112)

NCT ID: NCT01919112

Last Updated: 2020-07-21

Results Overview

This will be assessed using the Penetration and Aspiration Scale (PAS) scores, a validated 8 point ordinal scale that quantifies penetration and aspiration events observed during Videofluoroscopic Swallowing Evaluation. PAS ranges from 1 (best score) representing no aspiration or penetration to 8 (worst score) representing severe aspiration. An average PAS score will be computed based on 9 swallows for this outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: Scores will be measured before tDCS and after 5 days after completion of stimulation
• Results posted on: 2020-07-21

Participant Flow

All subjects were recruited from the inpatient neurology/stroke service at Beth Israel Deaconess Medical Center, Boston, MA. The first subject was recruited on 2/10/2014.

A total of 328 subjects were screened for the trial, of which 214 did not fulfill all trial criteria and 72 refused consent. A total of 42 subjects were eventually enrolled: 14 subjects in High-Dose tDCS, 13 in Low-Dose tDCS and 15 in Sham arms.

Participant milestones

Measure	High Dose Anodal tDCS High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
Primary Analysis-day 5 of Intervention STARTED	14	13	15
Primary Analysis-day 5 of Intervention COMPLETED	14	13	15
Primary Analysis-day 5 of Intervention NOT COMPLETED	0	0	0
Secondary Analysis-day 30 STARTED	14	13	15
Secondary Analysis-day 30 COMPLETED	12	12	14
Secondary Analysis-day 30 NOT COMPLETED	2	1	1

Reasons for withdrawal

Measure	High Dose Anodal tDCS High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
Secondary Analysis-day 30 Death	1	1	1
Secondary Analysis-day 30 Lost to Follow-up	1	0	0

Baseline Characteristics

Fostering Eating After Stroke With Transcranial Direct Current Stimulation

Baseline characteristics by cohort

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises	Total n=42 Participants Total of all reporting groups
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	39 Participants n=4 Participants
Age, Continuous	68 years STANDARD_DEVIATION 12.6 • n=5 Participants	72 years STANDARD_DEVIATION 13.3 • n=7 Participants	73 years STANDARD_DEVIATION 14.1 • n=5 Participants	71 years STANDARD_DEVIATION 13.2 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	14 participants n=5 Participants	13 participants n=7 Participants	15 participants n=5 Participants	42 participants n=4 Participants
Penetration and Aspiration Scale Score	4 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	4.1 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	4 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	4 units on a scale STANDARD_DEVIATION 1.3 • n=4 Participants

PRIMARY outcome

Timeframe: Scores will be measured before tDCS and after 5 days after completion of stimulation

Population: Analysis of participant was based on an intention to treat principle.

This will be assessed using the Penetration and Aspiration Scale (PAS) scores, a validated 8 point ordinal scale that quantifies penetration and aspiration events observed during Videofluoroscopic Swallowing Evaluation. PAS ranges from 1 (best score) representing no aspiration or penetration to 8 (worst score) representing severe aspiration. An average PAS score will be computed based on 9 swallows for this outcome.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Changes in Penetration and Aspiration	-0.4 score on a scale Standard Deviation 1.2	-0.8 score on a scale Standard Deviation 1.5	-0.8 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: During the 5 days of stimulation sessions

Population: Analyzed on an intention to treat as well as per protocol analysis

We will tabulate the number of participants who develop seizures in the High-dose anodal tDCS, Low-dose anodal tDCS and Sham stimulation groups.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Seizures in Each of the 3 Groups	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the 5 days of stimulation sessions

Population: Analyzed on an intention to treat as well as per protocol analysis

We will tabulate the number of deaths in High-dose tDCS, Low-dose tDCS and Sham stimulation groups, that are attributable to the direct effects of the qualifying stroke.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Deaths in Each of the 3 Groups Attributable to the Direct Effects of Stroke	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the 5 days of stimulation sessions

Population: Analyzed on an intention to treat as well as per protocol analysis

We will tabulate the number of participants who develop neurological deterioration in the High-dose tDCS, Low-dose tDCS and Sham groups. Neurological deterioration will be defined as an increase in the total National Institute of Health Stroke Scale (NIHSS) Score by 4 or more points between each successive day. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS ranges from 0 (normal) to 42 (worst possible score). Higher scores mean worse neurological functions.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Neurological Deterioration in Each of the 3 Groups	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the 5 days of stimulation sessions

Population: Analyzed on an intention to treat as well as per protocol analysis

We will tabulate the number of participants with deterioration in their motor functions in the High-dose tDCS, Low-dose tDCS and Sham groups. Motor deterioration will be defined as an increase in the motor sub-item of the National Institute of Health Stroke Scale (NIHSS) score by 2 or more points between each successive day of stimulation. The motor sub-item of the NIHSS ranges from 0 (normal) to 16 (worst possible score), with higher scores indicating a worse motor exam.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Motor Deterioration in Each of the 3 Groups	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Any change between day 1 and day 3 of stimulation session

Population: Analyzed on an intention to treat as well as per protocol analysis

We will tabulate the number of participants with swallowing deterioration in the High-dose tDCS, Low-dose tDCS and sham groups Swallowing deterioration will be defined as an increase in the score by 2 or more points in the Functional Oral Intake Scale (FOIS). FOIS provides a validated measure of diet level. FOIS is an ordinal scale ranging from 7 (normal diet) to 0 (no oral intake), with lower scores indicating a worse diet.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Swallowing Deterioration in Each of the 3 Groups	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At study onset and after 1 month

Population: Analyzed on an intention to treat analysis

The durability of any observed effects of the intervention on dietary status will be estimated by changes in Functional Oral Intake Scale (FOIS) score. FOIS is an ordinal scale ranging from 1 (worst) to 7 (normal oral diet) and provides a reliable measure of dietary intake. The change in FOIS scores across each group will be compared.

Outcome measures

Measure	High Dose Anodal tDCS n=12 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=12 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=14 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess and Compare Changes in Dietary Intake in Each of the Three Groups	2.9 score on a scale Standard Deviation 1.2	2.5 score on a scale Standard Deviation 1.7	2.1 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation

Population: Analyzed on an intention to treat as well as per protocol analysis

Examining effects of differing doses of anodal tDCS versus sham stimulation on Pharyngeal Constriction Ratio (PCR), derived from videofluoroscopic swallowing studies.PCR is a measure of the pharyngeal area visible in the lateral radiograph view at the point when a bolus is held in the oral cavity divided by the pharyngeal area at the point of maximum pharyngeal constriction during the swallow. A higher PCR indicates a weak swallow leading to increased food residue in the pharynx.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=13 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Changes in Physiological Measures of Pharyngeal Strength	-0.01 Ratio Standard Deviation 0.09	-0.1 Ratio Standard Deviation 0.12	-0.02 Ratio Standard Deviation 0.06

SECONDARY outcome

Timeframe: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation

Population: Analyzed on an intention to treat as well as per protocol analysis

Examining effects of differing doses of anodal tDCS versus sham stimulation on Pharyngeal Delay Time (PDT) , derived from videofluoroscopic swallowing studies. PDT is defined as the time in centiseconds that the bolus is present in the hypopharynx before the swallow is triggered. PDT is a temporal measure of the briskness of the swallow onset.

Outcome measures

Measure	High Dose Anodal tDCS n=13 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=11 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=14 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Changes in Physiological Measures of Briskness of Swallow Onset	5.2 centiseconds Standard Deviation 21.3	-7.3 centiseconds Standard Deviation 43.4	0.83 centiseconds Standard Deviation 20.6

SECONDARY outcome

Timeframe: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation

Population: Analyzed on an intention to treat as well as per protocol analysis

Examining effects of differing doses of anodal tDCS versus sham stimulation on measure of actual excursion of the larynx in centimeters from their resting point to maximal excursion, derived from videofluoroscopic swallowing studies.

Outcome measures

Measure	High Dose Anodal tDCS n=12 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=9 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=12 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
To Assess Changes in Physiological Measures of Laryngeal Excursion	0.07 centimeters Standard Deviation 0.81	0.17 centimeters Standard Deviation 1.4	0.14 centimeters Standard Deviation 0.67

SECONDARY outcome

Timeframe: At day 5 of study participation

We will examine the effects of the intervention in a linear model by using it as a predictor for dysphagia recovery along with other variables of interest [age, baseline National Institute of Health Stroke Scale and Penetration and Aspiration Scale (PAS) scores], with a change in PAS scores from baseline to day 5 of the intervention, as being the outcome of interest.

Outcome measures

Measure	High Dose Anodal tDCS n=14 Participants High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 Participants This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 Participants Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
Change in PAS Scores as an Indicator of Dysphagia Recovery After Covariate Adjustment	-0.34 score on a scale Standard Error 0.35	-0.81 score on a scale Standard Error 0.36	-0.96 score on a scale Standard Error 0.33

Adverse Events

High Dose Anodal tDCS

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Low Dose Anodal tDCS

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Sham Stimulation

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	High Dose Anodal tDCS n=14 participants at risk High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 participants at risk This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 participants at risk Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.1% 1/14 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/13 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/15 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).
Infections and infestations Pneumonia	0.00% 0/14 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	7.7% 1/13 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	13.3% 2/15 • Number of events 2 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).

Other adverse events

Measure	High Dose Anodal tDCS n=14 participants at risk High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Low Dose Anodal tDCS n=13 participants at risk This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises tDCS: Anodal tDCS will be administered with swallowing exercises	Sham Stimulation n=15 participants at risk Twice daily swallowing exercises only tDCS: Anodal tDCS will be administered with swallowing exercises
Infections and infestations Fever	14.3% 2/14 • Number of events 2 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/13 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	6.7% 1/15 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).
Endocrine disorders hyperglycemia	7.1% 1/14 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/13 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/15 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).
Gastrointestinal disorders diarrhea	0.00% 0/14 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	7.7% 1/13 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/15 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).
Cardiac disorders Tachycardia	0.00% 0/14 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/13 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	6.7% 1/15 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).
Infections and infestations Urinary tract infection	0.00% 0/14 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	7.7% 1/13 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/15 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).
Endocrine disorders Metabolic disorder	0.00% 0/14 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	0.00% 0/13 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).	6.7% 1/15 • Number of events 1 • Adverse event data were collected over the entire duration of patient follow-up (30 days since trial enrollment).

Additional Information

Sandeep Kumar, MD

Beth Israel Deaconess Medical Center

Phone: 617-632-8917

Email: skumar@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place