Trial Outcomes & Findings for Investigation and Modulation of the Mu-opioid Mechanisms in TMD (in Vivo) (NCT NCT03724032)

Last Updated: 2023-06-15

Results Overview

Change in clinical Visual Analog Scale pain score from baseline (Screening Day) to 4 weeks after completion of HD-tDCS sessions (Follow Up #2). Pain is measured on a scale of 1-10, with 10 being the worst.

Recruitment status

TERMINATED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Screening (Baseline), 4 Weeks after completion of HD-tDCS sessions

Results posted on

2023-06-15

Participant Flow

The study enrolled a total of 15 participants into the protocol. Secondary data from an additional 12 participants who participated in a prior study were also incorporated into the analysis for some secondary outcome measures as noted in the protocol section.

After consent to participate, subjects underwent evaluation to ensure eligibility into the study. Several patients screen failed at this stage of the study. Additional inclusion/exclusion criteria required by the sponsor were highly strict for our patient community and excluded the majority of volunteers who were pre-screened (490 total pre-screened).

Participant milestones

Participant milestones
Measure	TMD Patients Active Group: Active Comparator 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Overall Study STARTED	6	6	15
Overall Study COMPLETED	3	4	14
Overall Study NOT COMPLETED	3	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TMD Patients Active Group: Active Comparator 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Overall Study Physician Decision	1	0	0
Overall Study Protocol Violation	2	2	1

Baseline Characteristics

Investigation and Modulation of the Mu-opioid Mechanisms in TMD (in Vivo)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Screening (Baseline), 4 Weeks after completion of HD-tDCS sessions

Population: 2 subjects were excluded from analysis due to IRB requirements related to one pain measure threshold.

Outcome measures

Outcome measures
Measure	TMD Patients Active Group: Active Comparator n=2 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Change in Clinical Visual Analog Scale Pain Score From Baseline (Screening Day) to 4 Weeks After Completion of HD-tDCS Sessions (Follow Up #2).	-0.5 units on a scale Interval -0.7 to 0.6	-1.6 units on a scale Interval -5.4 to 2.2	—

SECONDARY outcome

Timeframe: Baseline, 1 Week after completion of HD-tDCS sessions

Change in clinical Visual Analog Scale pain score during sustained masseteric pain stress challenge from baseline PET (#1) session to follow-up PET (#2) session, 1 week after completion of HD-tDCS sessions.

Outcome measures

Outcome measures
Measure	TMD Patients Active Group: Active Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=4 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Change in Clinical Visual Analog Scale Pain Score During Sustained Masseteric Pain Stress Challenge From Baseline PET (#1) Session to Follow-up PET (#2) Session, 1 Week After Completion of HD-tDCS Sessions.	0 units on a scale Interval -2.5 to 2.5	0.2 units on a scale Interval -0.7 to 1.0	—

SECONDARY outcome

Timeframe: Baseline to 4 weeks after completion of HD-tDCS sessions

Population: 2 subjects were excluded from analysis due to IRB requirements related to one pain measure threshold.

Short- and long-term changes in GeoPain measures (percentage of pain area extension in the head region, average of pain intensity in the affected region, and their summation, meaning percentage of combined pain area and intensity in the affected region) from baseline daily over the treatment period and through follow-up at 4 weeks after completion of HD-tDCS sessions).

Outcome measures

Outcome measures
Measure	TMD Patients Active Group: Active Comparator n=2 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Changes in GeoPain Measures (PAINS - Summation of Area and Intensity) From Baseline Daily Over the Treatment Period and Through Follow-up (4 Weeks After Completion of HD-tDCS Sessions).	-4.8 percentage Interval -122.5 to 112.8	-2.1 percentage Interval -17.1 to 13.0	—

SECONDARY outcome

Timeframe: Baseline to 1 Week after completion of HD-tDCS sessions.

The difference in µOR BPND levels (a measure of receptor availability) between Baseline PET #1 and PET (#2) in TMD patients (active vs sham treatment groups). The values indicate changes in the availability of mu-opioid receptors (µOR), referred to as the non-displaceable binding potential (BPND), which reflects the density or concentration of available µORs in a particular region of interest in the brain, specifically the left thalamus. These changes are assessed by conducting baseline positron emission tomography (PET) scans prior to treatment and follow-up PET scans one week after the completion of HD-tDCS sessions. During each PET scan, µOR measurements are taken during an early resting phase. A positive value indicates increased µOR availability following treatment, while a negative value indicates decreased availability after treatment.

Outcome measures

Outcome measures
Measure	TMD Patients Active Group: Active Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=4 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Difference in µOR BPND Levels of Thalamus From Baseline PET (#1) Session to Follow-up PET (#2) Session, 1 Week After Completion of HD-tDCS Sessions.	0.05 arbitrary units Interval 0.03 to 0.07	-0.02 arbitrary units Interval -0.2 to 0.2	—

SECONDARY outcome

Timeframe: Baseline, 1 Week after completion of HD-tDCS sessions.

Change in clinical Visual Analog Scale pain score at rest from baseline PET (#1) session to follow-up PET (#2) session, 1 week after completion of HD-tDCS sessions.

Outcome measures

Outcome measures
Measure	TMD Patients Active Group: Active Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=4 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Change in Clinical Visual Analog Scale Pain Score at Rest From Baseline PET (#1) Session to Follow-up PET (#2) Session, 1 Week After Completion of HD-tDCS Sessions.	-2.5 units on a scale Interval -10.2 to 5.1	0.2 units on a scale Interval -0.6 to 1.1	—

SECONDARY outcome

Timeframe: During PET #1, at rest (5-40 mins after radiotracer injection)

The difference in µOR BPND levels (a measure of receptor availability) at rest (5-40 mins after radiotracer injection) during baseline PET in TMD patients as compared to healthy subjects. The values for each group the availability of mu-opioid receptors (µOR), referred to as the non-displaceable binding potential (BPND), which reflects the density or concentration of available µORs in a particular region of interest in the brain, specifically the left thalamus. It was assessed by conducting baseline positron emission tomography (PET) scans. The outcome measure 6 was taken during an early-resting (outcome 6)

Outcome measures

Outcome measures
Measure	TMD Patients Active Group: Active Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=4 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group n=14 Participants 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Difference in µOR BPND Levels at Rest During PET (#1) in Chronic TMD Patients as Compared to Healthy Subjects.	1.8 arbitrary units Interval 0.7 to 2.9	1.5 arbitrary units Interval 1.3 to 1.8	1.5 arbitrary units Interval 1.4 to 1.6

SECONDARY outcome

Timeframe: PET (#1) during experimental sustained masseteric pain stress challenge (45-90 mins after radiotracer injection)

Difference in µOR BPND levels (a measure of receptor availability) at experimental sustained masseteric pain stress challenge (45-90 mins after radiotracer injection) during baseline PET in TMD patients as compared to healthy subjects. The values for each group the availability of mu-opioid receptors (µOR), referred to as the non-displaceable binding potential (BPND), which reflects the density or concentration of available µORs in a particular region of interest in the brain, specifically the left thalamus. It was assessed by conducting baseline positron emission tomography (PET) scans. The outcome measure 7 was taken during a late pain stimulus (hypertonic saline infusion) phase.

Outcome measures

Outcome measures
Measure	TMD Patients Active Group: Active Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=4 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group n=14 Participants 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.
Difference in µOR BPND Levels During Experimental Sustained Masseteric Pain Stress Challenge During PET (#1) in Chronic TMD Patients as Compared to Healthy Subjects	1.7 arbitrary units Interval 0.5 to 2.9	1.5 arbitrary units Interval 1.2 to 1.8	1.5 arbitrary units Interval 1.4 to 1.6

Adverse Events

Active TMD Patients

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham TMD Patients

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active TMD Patients n=4 participants at risk TMD patients who received active HD-tDCS treatment for 10 days	Sham TMD Patients n=4 participants at risk TMD patients who complete 10 sham treatments	Healthy Volunteers n=15 participants at risk Healthy Volunteers did not receive treatment.
Investigations Headache	75.0% 3/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	25.0% 1/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	0.00% 0/15 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.
Investigations Scalp Pain	50.0% 2/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	25.0% 1/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	0.00% 0/15 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.
Investigations Scalp Burn sensation (mild)	25.0% 1/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	25.0% 1/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	0.00% 0/15 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.
Investigations Tingling	50.0% 2/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	75.0% 3/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	0.00% 0/15 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.
Investigations sleepiness	50.0% 2/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	25.0% 1/4 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.	0.00% 0/15 • During the 2-weeks of HD-tDCS treatment Adverse Events were collected using a questionnaire that reflects common side effects of tDCS treatment. The questionnaire was administered before and after each of 10 tDCS treatment sessions. All of the adverse events reported were expected and mild in severity.

Additional Information

Jacqueline Dobson

University of Michigan

Phone: 734-763-8469

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	TMD Patients Active Group: Active Comparator n=3 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 20 minute sessions, once daily for 10 days (M-F for 2 weeks). HD-tDCS\: Non-invasive brain stimulation (active protocol)	TMD Patients Sham Group: Sham Comparator n=4 Participants 30 TMD patients will be randomized (Taves method) to receive high-definition transcranial direct current stimulation (HD-tDCS\) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 10 days (M-F for 2 weeks). Sham HD-tDCS\: Non-invasive brain stimulation (sham protocol)	Healthy Control Group n=14 Participants 20 Healthy Volunteers will be asked to undergo baseline assessments only (including imaging, but no brain stimulation). Healthy volunteer data (n \</= 10) may be used from a prior study (NIDCR-R56-DE022637 project \[IRBMED #HUM00080911; Dr. Alexandre DaSilva, Principal Investigator\]). Consent to use data for a future study was obtained in the informed consent document at the time of participation.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants	21 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	28.0 years STANDARD_DEVIATION 6.2 • n=5 Participants	30.4 years STANDARD_DEVIATION 9.1 • n=7 Participants	27.6 years STANDARD_DEVIATION 8.2 • n=5 Participants	28.2 years STANDARD_DEVIATION 7.8 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants	20 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants	18 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	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	14 participants n=5 Participants	21 participants n=4 Participants