Trial Outcomes & Findings for Hippocampal Stimulation in Chronic Low Back Pain (NCT NCT04888494)
NCT ID: NCT04888494
Last Updated: 2023-06-15
Results Overview
The endpoint will be the severity of pain measured by changes in the Numeric Rating Scale (NRS) scores before and after each stimulation round. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." Higher values indicate a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Pain is assessed at baseline, end of first intervention and end of the second intervention.
Results posted on
2023-06-15
Participant Flow
Participants were screened via a database maintained by one of the co-investigators. The first participant was enrolled on June 25, 2021, and the last participant was enrolled in February 2022.
Of the 44 participants screened, 16 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Hippocampus-stimulation First Then Sham-stimulation
Over five consecutive days, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which is determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. Each daily stimulation session lasts about 20 minutes.
After a two-week washout period, we administer sham stimulation with identical parameters except that the coil is flipped over to the sham side, and a stimulating electrode is attached to the skin near the parietal rTMS target location. This electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to discriminate between the two types of stimulation.
|
Sham-stimulation First Then Hippocampus-stimulation
For five consecutive days, we administer sham stimulation by flipping the coil over to the sham side and attaching a stimulating electrode to the skin near the parietal rTMS target location. The electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to distinguish between the two types of stimulation. Each daily stimulation session lasts around 20 minutes.
After a two-week washout period, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which will be determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
First Intervention (5 Days)
|
5
|
5
|
|
Overall Study
Washout (14 Days)
|
5
|
5
|
|
Overall Study
Second Intervention (5 Days)
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Hippocampus-stimulation First Then Sham-stimulation
Over five consecutive days, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which is determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. Each daily stimulation session lasts about 20 minutes.
After a two-week washout period, we administer sham stimulation with identical parameters except that the coil is flipped over to the sham side, and a stimulating electrode is attached to the skin near the parietal rTMS target location. This electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to discriminate between the two types of stimulation.
|
Sham-stimulation First Then Hippocampus-stimulation
For five consecutive days, we administer sham stimulation by flipping the coil over to the sham side and attaching a stimulating electrode to the skin near the parietal rTMS target location. The electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to distinguish between the two types of stimulation. Each daily stimulation session lasts around 20 minutes.
After a two-week washout period, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which will be determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
We dropped the participant due to safety concerns for the staff.
|
1
|
0
|
Baseline Characteristics
Hippocampal Stimulation in Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Hippocampus-stimulation First, Then Sham-stimulation
n=5 Participants
Over five consecutive days, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which is determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. Each daily stimulation session lasts about 20 minutes.
After a two-week washout period, we administer sham stimulation with identical parameters except that the coil is flipped over to the sham side, and a stimulating electrode is attached to the skin near the parietal rTMS target location. This electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to discriminate between the two types of stimulation.
|
Sham-stimulation Then Hippocampus Stimulation
n=5 Participants
For five consecutive days, we administer sham stimulation by flipping the coil over to the sham side and attaching a stimulating electrode to the skin near the parietal rTMS target location. The electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to distinguish between the two types of stimulation. Each daily stimulation session lasts around 20 minutes.
After a two-week washout period, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which will be determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 18 • n=5 Participants
|
52 years
STANDARD_DEVIATION 15 • n=7 Participants
|
55 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Baseline Pain
|
4.6 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pain is assessed at baseline, end of first intervention and end of the second intervention.The endpoint will be the severity of pain measured by changes in the Numeric Rating Scale (NRS) scores before and after each stimulation round. The NRS is a pain screening tool that assesses pain severity during assessment using a 0-10 scale, where zero means "no pain" and ten means "the worst pain imaginable." Higher values indicate a worse outcome.
Outcome measures
| Measure |
Hippocampus-stimulation
n=10 Participants
Over five consecutive days, we use repetitive transcranial magnetic stimulation (rTMS) at the resting motor threshold intensity to stimulate a region of interest in the parietal cortex, which is determined based on its connectivity with the hippocampus. The rTMS consists of 1,600 pulses delivered in 2-second periods of 20 Hz pulse trains, with 28-second inter-train intervals. Each daily stimulation session lasts about 20 minutes.
|
Sham-stimulation
n=10 Participants
For five consecutive days, we administer sham stimulation by flipping the coil over to the sham side and attaching a stimulating electrode to the skin near the parietal rTMS target location. The electrode delivers a small current to mimic the physical sensation of real stimulation, making it difficult for participants to distinguish between the two types of stimulation. Each daily stimulation session lasts around 20 minutes.
|
|---|---|---|
|
Changes in Pain Scales
Baseline
|
4.6 units on a scale
Standard Deviation 1.9
|
4.6 units on a scale
Standard Deviation 1.9
|
|
Changes in Pain Scales
After Intervention
|
4 units on a scale
Standard Deviation 2.2
|
4.4 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: approximately 6 weeks - Baseline and after the end of hippocampal stimulationPopulation: The data was not collected due to the COVID-19 pandemic.
Changes in hippocampal network connectivity will be evaluated by using resting state functional magnetic resonance (fMRI) before and after hippocampal stimulation. Hippocampal connectivity measurements - regions involved in the network and the parietal target - will be compared before stimulation (baseline) to after stimulation (after active hippocampal stimulation).
Outcome measures
Outcome data not reported
Adverse Events
Hippocampus-stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham-stimulation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place