Trial Outcomes & Findings for H-coil TMS to Reduce Pain: A Pilot Study Evaluating Relative Efficacy of the H1 vs H7 Coil (NCT NCT04203199)
NCT ID: NCT04203199
Last Updated: 2023-09-15
Results Overview
Based on pilot data, the investigators expect an interaction between treatment (DLPFC or MPFC TMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique which determines the sensation and pain thresholds of pressure. Painfulness ratings will be assessed and reported before and after rTMS.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
rTMS treatment visit, an average of 2 and a half hours
Results posted on
2023-09-15
Participant Flow
There were 8 screen failures. Only 31 randomized.
Participant milestones
| Measure |
First H1 Coil, Then H7 Coil
There will be 1 screening and 2 TMS visits. The procedures will be identical for each TMS visit, except for the type of TMS delivered (H1 or H7 coil). Each participant will be assigned to both coils, with TMS type. Participants assigned to this arm will receive the H1 coil at TMS visit 1, H7 coil at TMS visit 2
Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
First H7 Coil, Then H1 Coil
There will be 1 screening and 2 TMS visits. The procedures will be identical for each TMS visit, except for the type of TMS delivered (H1 or H7 coil). Each participant will be assigned to both coils, with TMS type. Participants assigned to this arm will receive the H7 coil at TMS visit 1, H1 coil at TMS visit 2.
Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
|---|---|---|
|
First Intervention Period
STARTED
|
15
|
16
|
|
First Intervention Period
COMPLETED
|
15
|
15
|
|
First Intervention Period
NOT COMPLETED
|
0
|
1
|
|
Second Intervention Period
STARTED
|
15
|
15
|
|
Second Intervention Period
COMPLETED
|
14
|
15
|
|
Second Intervention Period
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
First H1 Coil, Then H7 Coil
There will be 1 screening and 2 TMS visits. The procedures will be identical for each TMS visit, except for the type of TMS delivered (H1 or H7 coil). Each participant will be assigned to both coils, with TMS type. Participants assigned to this arm will receive the H1 coil at TMS visit 1, H7 coil at TMS visit 2
Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
First H7 Coil, Then H1 Coil
There will be 1 screening and 2 TMS visits. The procedures will be identical for each TMS visit, except for the type of TMS delivered (H1 or H7 coil). Each participant will be assigned to both coils, with TMS type. Participants assigned to this arm will receive the H7 coil at TMS visit 1, H1 coil at TMS visit 2.
Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
|---|---|---|
|
First Intervention Period
Lost to Follow-up
|
0
|
1
|
|
Second Intervention Period
Medication change
|
1
|
0
|
Baseline Characteristics
H-coil TMS to Reduce Pain: A Pilot Study Evaluating Relative Efficacy of the H1 vs H7 Coil
Baseline characteristics by cohort
| Measure |
First H1 Coil, Then H7 Coil
n=15 Participants
There will be 1 screening and 2 TMS visits. The procedures will be identical for each TMS visit, except for the type of TMS delivered (H1 or H7 coil). Each participant will be assigned to both coils, with TMS type. Participants assigned to this arm will receive the H1 coil at TMS visit 1, H7 coil at TMS visit 2
Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
First H7 Coil, Then H1 Coil
n=16 Participants
There will be 1 screening and 2 TMS visits. The procedures will be identical for each TMS visit, except for the type of TMS delivered (H1 or H7 coil). Each participant will be assigned to both coils, with TMS type. Participants assigned to this arm will receive the H7 coil at TMS visit 1, H1 coil at TMS visit 2.
Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.27 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
43.88 years
STANDARD_DEVIATION 15.4 • n=7 Participants
|
47.45 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: rTMS treatment visit, an average of 2 and a half hoursBased on pilot data, the investigators expect an interaction between treatment (DLPFC or MPFC TMS) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique which determines the sensation and pain thresholds of pressure. Painfulness ratings will be assessed and reported before and after rTMS.
Outcome measures
| Measure |
Real rTMS to the mPFC Using H7 Coil
n=29 Participants
One session of low frequency repetitive transcranial magnetic stimulation (rTMS) will be delivered to the left medial prefrontal cortex (mPFC) using the H7-coil (20 min total, 1200 pulses delivered at 1 Hz continuously, 1 train, 120% resting motor threshold (rMT)). Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
|
Real rTMS to the dlPFC Using H1 Coil
n=29 Participants
One session of high frequency repetitive transcranial magnetic stimulation (rTMS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) using the H1-coil (20 min total, 3000 pulses delivered at 10 Hz, 60 trains, 50 pulses/train, 5 sec on/15 sec off, 120% resting motor threshold (rMT)). Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
|---|---|---|
|
Changes in Painfulness Thresholds Using the Quantitative Pain Testing (QST) Task, Which Utilizes Pressure From the Medoc Algomed Device (Measured in kiloPascals).
|
1.1 kPascals
Standard Deviation 101.3
|
-23.4 kPascals
Standard Deviation 89
|
SECONDARY outcome
Timeframe: rTMS treatment visit, an average of 2 and a half hoursThe investigators do not expect an interaction between treatment (DLPFC or MPFC TMS) and time (Before vs. After rTMS) on pain tolerance thresholds using a quantitative sensory testing technique which determines the sensation and pain thresholds of pressure. Pain tolerance ratings will be assessed and reported before and after rTMS.
Outcome measures
| Measure |
Real rTMS to the mPFC Using H7 Coil
n=29 Participants
One session of low frequency repetitive transcranial magnetic stimulation (rTMS) will be delivered to the left medial prefrontal cortex (mPFC) using the H7-coil (20 min total, 1200 pulses delivered at 1 Hz continuously, 1 train, 120% resting motor threshold (rMT)). Real rTMS to the mPFC using H7 Coil: This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
|
Real rTMS to the dlPFC Using H1 Coil
n=29 Participants
One session of high frequency repetitive transcranial magnetic stimulation (rTMS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) using the H1-coil (20 min total, 3000 pulses delivered at 10 Hz, 60 trains, 50 pulses/train, 5 sec on/15 sec off, 120% resting motor threshold (rMT)). Real rTMS to the dlPFC using H1 Coil: This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
|
|---|---|---|
|
Changes in Pain Tolerance Thresholds Using the Quantitative Pain Testing (QST) Task, Which Utilizes Pressure From the Medoc Algomed Device (Measured in kiloPascals).
|
4.8 kPascals
Standard Deviation 117.9
|
24.2 kPascals
Standard Deviation 134.4
|
Adverse Events
Real rTMS to the mPFC Using H7 Coil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Real rTMS to the dlPFC Using H1 Coil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Colleen Hanlon, PhD
Wake Forest University Health Sciences
Phone: 844-386-7001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place