Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:06 AM
NCT ID: NCT03237234
Description: None
Frequency Threshold: 0
Time Frame: Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
Study: NCT03237234
Study Brief: Enhancing Corticospinal Activation for Improved Walking Function
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Motor Skill Training + Sham tDCS (MST+Sham-tDCS) Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS). MST: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test. 0 None 0 14 2 14 View
Motor Skill Training + tDCS (MST+tDCS) Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex. Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test. Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities. 0 None 0 11 6 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Moderate Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Muscle Soreness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Suprapubic Catheter Irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thumb Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View