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:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-25 @ 12:53 PM
NCT ID:
NCT01915095
Description:
None
Frequency Threshold:
0
Time Frame:
The adverse event data was collected from baseline to completion of study visits for each participant, an average of 6 days for Arm 1 and an average of 3 weeks for Arm 2 and 3.
Study:
NCT01915095
Study Brief:
Improving Motor Function After Spinal Cord Injury
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Wrist Flexion and Precision Grip + rTMS and Sham rTMS | This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist flexion and precision grip + rTMS; 2. Wrist flexion and precision grip + Sham rTMS. Participants will complete two study visits each lasting \~2 hours separated by at least two days. In the Wrist flexion and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as flexing the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. Wrist flexion and precision grip + Sham rTMS: The same procedures listed above will be completed before and after Sham rTMS. | 0 | None | 0 | 10 | 0 | 10 | View |
| Wrist Extension and Precision Grip + rTMS and Sham rTMS | This study arm is a crossover design. Participants will complete the following two randomized sessions: 1. Wrist extension and precision grip + rTMS; 2. Wrist extension and precision grip + Sham rTMS. Participants will complete two study visits each lasting \~2 hours separated by at least two days. In the Wrist extension and precision grip + rTMS study visit, participants are asked to complete a precision grip with the index and thumb finger at the same time as extending the wrist. Transcranial magnetic stimuli (TMS) to the brain will be administered and TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. Wrist extension and precision grip + Sham rTMS: The same procedures listed above will be completed before and after Sham rTMS. | 0 | None | 0 | 10 | 0 | 10 | View |
| Training + rTMS | Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement. Magnetic stimulation will be given during rest and movement. rTMS: small magnetic pulses will be given to the brain in a non invasive manner. Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. This is called training | 0 | None | 0 | 4 | 0 | 4 | View |
| Training + Sham rTMS | Participants will be asked to follow a target line on the computer as accurately as possible while performing precision grips or foot movement. Magnetic stimulation will be given during rest and movement. Sham rTMS: sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner Training: at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. This is called training | 0 | None | 0 | 3 | 0 | 3 | View |
| rTMS/Sham rTMS/Sham rTMS Over Control Brain Area | This study arm is a 3 way crossover design. Participants are randomized to one of the 3 study groups: rTMS, Sham rTMS, and Sham rTMS over control brain area. Participants will complete all study groups. Each study group consists of one study visit lasting \~2 hours and there is a 1 week washout period between each study visit. rTMS stimulation: In this group, rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of motor evoked potentials (MEPs) will be taken at minute 0, 10, 30, and 60. The maximum voluntary contraction (MVC) will be measured using surface EMG before rTMS and again after. Sham or fake rTMS stimulation: In this group, Sham rTMS stimulation will be targeting finger and wrist muscles during precision grip. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after. Sham rTMS over control brain area: In this group, Sham rTMS will be applies over the dorsolateral prefrontal cortex (DLPFC) or at the leg presentation of the primary motor cortex, or at other related control area. TMS measurements in the form of MEPs will be taken at minute 0, 10, 30, and 60. The MVC will be measured using surface EMG before rTMS and again after. Participants are asked to wait a 1 week washout period between sessions. | 0 | None | 0 | 5 | 0 | 5 | View |
Serious Events(If Any):
Other Events(If Any):