Trial Outcomes & Findings for Treatment and Recovery Monitoring of Post TBI Symptoms (NCT NCT02426749)
NCT ID: NCT02426749
Last Updated: 2022-06-14
Results Overview
RPQ is the Rivermead Post Concussion Symptoms Questionnaire. Scale ranges from 0 to 64 points, with higher scores representing a greater number or severity of reported symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Immediately following treatment (4 weeks after baseline)
Results posted on
2022-06-14
Participant Flow
Participant milestones
| Measure |
Active Coil
Participants of this arm received active rTMS intervention (treatment).
Active repetitive Transcranial Magnetic Stimulation (rTMS): The treatments were administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups received rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC on the left side at 100% of the resting motor threshold. Thus, there was a total of 750 pulses per day, which was well within the safety limit of the rTMS application.
|
Sham
Participants of this arm received sham rTMS intervention (treatment).
Sham repetitive Transcranial Magnetic Stimulation (rTMS): Sham rTMS was similar to Active rTMS but instead of a real coil, it used a coil that attenuates the pulses such that no current will be induced in the brain.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Coil
n=9 Participants
Participants of this arm received active rTMS intervention (treatment). Active repetitive Transcranial Magnetic Stimulation (rTMS): The treatments were administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups received rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC on the left side at 100% of the resting motor threshold. Thus, there was a total of 750 pulses per day, which was well within the safety limit of the rTMS application.
|
Sham
n=9 Participants
Participants of this arm received sham rTMS intervention (treatment). Sham repetitive Transcranial Magnetic Stimulation (rTMS): Sham rTMS was similar to Active rTMS but instead of a real coil, it used a coil that attenuates the pulses such that no current will be induced in the brain.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
16 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 16.1 • n=9 Participants
|
53.4 years
STANDARD_DEVIATION 9.2 • n=9 Participants
|
50.3 years
STANDARD_DEVIATION 13.2 • n=18 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
18 participants
n=18 Participants
|
|
MoCA score
|
28.1 units on a scale
STANDARD_DEVIATION 1.17 • n=9 Participants
|
27.1 units on a scale
STANDARD_DEVIATION 2.98 • n=9 Participants
|
27.6 units on a scale
STANDARD_DEVIATION 2.25 • n=18 Participants
|
PRIMARY outcome
Timeframe: Immediately following treatment (4 weeks after baseline)RPQ is the Rivermead Post Concussion Symptoms Questionnaire. Scale ranges from 0 to 64 points, with higher scores representing a greater number or severity of reported symptoms.
Outcome measures
| Measure |
Active Coil
n=9 Participants
Participants of this arm will receive active rTMS intervention (treatment).
|
Sham
n=9 Participants
Participants of this arm will receive sham rTMS intervention (treatment).
|
|---|---|---|
|
Change From Baseline in RPQ Score at Post-treatment Sessions
|
-4.6 units on a scale
Standard Deviation 10.2
|
-3.4 units on a scale
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: Immediately following treatment (4 weeks after baseline)EVestG is the Electrovestibulography assessment, in which features of the neural field potential are extracted. The measurement here is a calculation of the area under the AP curve. The area is a product of the number of samples (1 / 41667 s each) and the normalized voltage (normalized so the field potential peak has a magnitude of 1). The result is summed over all detected field potentials. Due to the normalization, in a practical sense this value gives a metric of how wide or narrow the calculated field potential shape is.
Outcome measures
| Measure |
Active Coil
n=9 Participants
Participants of this arm will receive active rTMS intervention (treatment).
|
Sham
n=9 Participants
Participants of this arm will receive sham rTMS intervention (treatment).
|
|---|---|---|
|
Change From Baseline in EVestG Field Potential's Features at Post Treatment Sessions
|
5.64 product of normalized voltage & samples
Standard Deviation 10.75
|
3.08 product of normalized voltage & samples
Standard Deviation 7.01
|
SECONDARY outcome
Timeframe: Immediately following treatment (4 weeks after baseline)MoCA is the Montreal Cognitive Assessment; the scale ranges from 0 to 30 points. Higher scores indicate a higher cognitive ability.
Outcome measures
| Measure |
Active Coil
n=9 Participants
Participants of this arm will receive active rTMS intervention (treatment).
|
Sham
n=9 Participants
Participants of this arm will receive sham rTMS intervention (treatment).
|
|---|---|---|
|
Change From Baseline in MoCA Score at Post-treatment Sessions.
|
0.33 score on a scale
Standard Deviation 1.73
|
0.67 score on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Immediately following treatment (4 weeks after baseline)MADRS is the Montgomery Asberg Depression Rating Scale. Scores range from 0 to 60, with higher scores meaning that the subject has a higher degree of depression.
Outcome measures
| Measure |
Active Coil
n=9 Participants
Participants of this arm will receive active rTMS intervention (treatment).
|
Sham
n=9 Participants
Participants of this arm will receive sham rTMS intervention (treatment).
|
|---|---|---|
|
Change From Baseline in MADRS Score at Post-treatment Sessions
|
-3.22 score on a scale
Standard Deviation 4.87
|
-2.33 score on a scale
Standard Deviation 7.42
|
Adverse Events
Active Coil
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Coil
n=9 participants at risk
Participants of this arm will receive active rTMS intervention (treatment).
Active repetitive Transcranial Magnetic Stimulation (rTMS): The treatments will be administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups will undergo rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC bilaterally at 100% of the resting motor threshold. Thus, there will be a total of 1500 pulses per two sides of the brain per day, which is well within the safety limit of the rTMS application. During the intertrain intervals, the patients will be presented a series of objects and actions and asking to name them. The images will be projected on the wall in front of patient with duration of three seconds for each image. The aim is to keep the brain active while we stimulate it with rTMS.
|
Sham
n=9 participants at risk
Participants of this arm will receive sham rTMS intervention (treatment).
Sham repetitive Transcranial Magnetic Stimulation (rTMS): Sham rTMS is similar to Active rTMS but instead of a real coil, it uses a coil that attenuates the pulses such that no current will be induced in the brain.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Headache
|
11.1%
1/9 • Number of events 1 • 3 months
|
0.00%
0/9 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place