Trial Outcomes & Findings for Neuromodulation and Yoga for Mild Traumatic Brain Injury and Chronic Pain (NCT NCT04517604)
NCT ID: NCT04517604
Last Updated: 2025-07-16
Results Overview
For feasibility, we will track the number of iTBS+yoga sessions completed and compute completion percentage rates for each participant as a metric of feasibility.
COMPLETED
NA
19 participants
Endpoint - after last iTBS+yoga session, approximately 6 weeks
2025-07-16
Participant Flow
We recruited treatment-seeking Veterans from Edward Hines Jr., VA Hospital Recruitment Period: 6/2021 to 6/2023 Types of Location: Suburban VA Hospital and associated relevant clinics such as the Polytrauma/TBI clinic.
Participants were screened over the phone with a delimited set of measures but more in-depth screening for full eligibility criteria occurred after consent/enrollment. Thus, only enrolled participants meeting full eligibility criteria were allowed to move forward and assigned to receive the treatment intervention.
Participant milestones
| Measure |
iTBS+Yoga
Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.
Magventure MagProx100 with MagOption: The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.
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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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9
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants that completed baseline assessments are included which is an n=14.
Baseline characteristics by cohort
| Measure |
Open Label iTBS+Yoga
n=19 Participants
All patients received individual approximately 3-minute iTBS session followed by a 90-minute group LoveYourBrain yoga session. iTBS+yoga sessions occurred once a week for 6 weeks.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=19 Participants
|
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Age, Categorical
Between 18 and 65 years
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19 Participants
n=19 Participants
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Age, Categorical
>=65 years
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0 Participants
n=19 Participants
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Age, Continuous
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43.1 years
n=19 Participants
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Sex/Gender, Customized
Gender · cisgender men
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13 Participants
n=19 Participants
|
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Sex/Gender, Customized
Gender · cisgender women
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5 Participants
n=19 Participants
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Sex/Gender, Customized
Gender · transgender men
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1 Participants
n=19 Participants
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Sex/Gender, Customized
Gender · transgender women
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0 Participants
n=19 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=19 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=19 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=19 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=19 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=19 Participants
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Race (NIH/OMB)
Black or African American
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7 Participants
n=19 Participants
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Race (NIH/OMB)
White
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9 Participants
n=19 Participants
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Race (NIH/OMB)
More than one race
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2 Participants
n=19 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
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Region of Enrollment
United States
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19 Participants
n=19 Participants
|
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Brief Pain Inventory - Pain Severity
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5.59 units on a scale
STANDARD_DEVIATION 1.36 • n=14 Participants • All participants that completed baseline assessments are included which is an n=14.
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Brief Pain Inventory - Pain Interference
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4.24 units on a scale
STANDARD_DEVIATION 2.80 • n=14 Participants • All participants who completed baseline measures are included which is an n=14.
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Mayo-Portland Adaptability Inventory (MPAI-4) - Total
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39.3 T-Score
STANDARD_DEVIATION 9.03 • n=14 Participants • All participants who participated in baseline assessments are reported which is an n=14.
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Mayo-Portland Adaptability Inventory (MPAI-4) - Ability
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39.7 T-Score
STANDARD_DEVIATION 9.87 • n=14 Participants • All participants who completed baseline assessments are included which is an n=14.
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Mayo-Portland Adaptability Inventory (MPAI-4) - Participation
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31.5 T-Score
STANDARD_DEVIATION 10.6 • n=14 Participants • All participants who completed baseline assessments which is an n=14 are included.
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Mayo-Portland Adaptability Inventory (MPAI-4) - Adjustment
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46.7 T-Score
STANDARD_DEVIATION 7.49 • n=14 Participants • All participants that completed baseline assessments are included which is an n=14.
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PRIMARY outcome
Timeframe: Endpoint - after last iTBS+yoga session, approximately 6 weeksPopulation: 14 participants initiated iTBS+yoga treatment sessions and could possibly complete 6 total number of intervention sessions. Thus total number of possible sessions is 14 x 6 = 84
For feasibility, we will track the number of iTBS+yoga sessions completed and compute completion percentage rates for each participant as a metric of feasibility.
Outcome measures
| Measure |
iTBS+Yoga
n=84 number of sessions
Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.
Magventure MagProx100 with MagOption: The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.
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|---|---|
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Session Completion Rate
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60 number of sessions
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SECONDARY outcome
Timeframe: Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)Population: Analysis completed on the 10 iTBS+yoga treatment completers
The Mayo-Portland Adaptability Index is a TBI Common Data Element assessment of function and participation. It includes 35 items each scored on a scale of 0 to 4, with 0 meaning no problems (better), and 4 meaning severe problems (worse). Minimum (best) score would be 0 and maximum (worst) score would be 140.
Outcome measures
| Measure |
iTBS+Yoga
n=10 Participants
Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.
Magventure MagProx100 with MagOption: The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.
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|---|---|
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Mayo-Portland Adaptability Index - Total
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35.2 score on a scale
Standard Deviation 17.4
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SECONDARY outcome
Timeframe: Endpoint (after last iTBS+yoga treatment, approximately 6 weeks)Population: Analysis completed on the 10 iTBS+yoga treatment completers
The Brief Pain Inventory is a self-report measure of pain symptoms throughout the body. It has 4 main items and each item is scored on a scale of 0 to 10 with 0 meaning no pain (better), and 10 meaning pain as bad as you can imagine (worse). Minimum (best) score would be 0 and maximum (worst) score would be 40.
Outcome measures
| Measure |
iTBS+Yoga
n=10 Participants
Participants will receive 6 sessions of intermittent theta burst stimulation (iTBS) and the LoveYourBrain Yoga program. The LoveYourBrain Yoga program was specifically designed for people with TBI.
Magventure MagProx100 with MagOption: The Magventure C-B60 butterfly coil will be used for single-pulse TMS to determine motor threshold. iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B65 Butterfly coils) or active-only Cool-B65 Butterfly (figure 8) coil. Only the active setting will be used.
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|---|---|
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Brief Pain Inventory - Pain Severity
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3.7 score on a scale
Standard Deviation 1.5
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Adverse Events
Open Label iTBS+Yoga
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label iTBS+Yoga
n=19 participants at risk
All patients received individual approximately 3-minute iTBS session followed by a 90-minute group LoveYourBrain yoga session. iTBS+yoga sessions occurred once a week for 6 weeks.
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|---|---|
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Nervous system disorders
headache
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15.8%
3/19 • Number of events 3 • 6 weeks
Safety data on safety indicators was collected at each iTBS session including the following: hypertension, hypotension, heart rate, oxygen saturation, sleep, fatigue medication changes, seizure, headache/neck pain, fever, fainting, scalp/skin breakdown, tinnitus, dizziness, nausea, vomiting, confusion, and contraindicated substance use. Adverse event reporting logs were completed and reported to the IRB.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place