Trial Outcomes & Findings for Central Pain Syndrome in Survivors of Head and Neck Cancer (NCT NCT04128267)
NCT ID: NCT04128267
Last Updated: 2022-09-19
Results Overview
MRI scan of brain to measure response to stimulated pressure to thumbnail
TERMINATED
NA
32 participants
Approximately 8 weeks
2022-09-19
Participant Flow
This study enrolled participants at Vanderbilt University Medical Center from November 4, 2019 to July 21, 2022. The study stopped early due to low accrual and technical issues with equipment.
Participant milestones
| Measure |
Response to Pain
Brain's response to pain using magnetic resonance imaging (MRI)
IPC-1000: Delivers pressure to thumbnail for five seconds at a time
Magnetic resonance imaging: Scan of brain using Magnetic resonance imaging
Correlative Studies: Administration of questionnaires via computer
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Response to Pain
Brain's response to pain using magnetic resonance imaging (MRI)
IPC-1000: Delivers pressure to thumbnail for five seconds at a time
Magnetic resonance imaging: Scan of brain using Magnetic resonance imaging
Correlative Studies: Administration of questionnaires via computer
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease progression
|
1
|
|
Overall Study
Participant had other medical issues
|
4
|
|
Overall Study
Participant failed to respond to multiple attempts to contact
|
2
|
Baseline Characteristics
Central Pain Syndrome in Survivors of Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Response to Pain
n=32 Participants
Brain's response to pain using magnetic resonance imaging (MRI)
IPC-1000: Delivers pressure to thumbnail for five seconds at a time
Magnetic resonance imaging: Scan of brain using Magnetic resonance imaging
Correlative Studies: Administration of questionnaires via computer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Approximately 8 weeksPopulation: Data were not collected due to the technical issues.
MRI scan of brain to measure response to stimulated pressure to thumbnail
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Approximately 8 weeksPopulation: Data were not collected due to the technical issues.
MRI scan of brain to measure response to stimulated pressure to thumbnail
Outcome measures
Outcome data not reported
Adverse Events
Response to Pain
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place