Trial Outcomes & Findings for Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain (NCT NCT04156802)

Last Updated: 2023-05-12

Results Overview

The investigators expect changes in self reported qualitative pain assessment via a numeric pain rating scale when comparing active vs sham. Pain rating values will be assessed and reported through the duration of the study. Percent change from baseline values ranged from -100 to 500. Larger, positive values represent increased pain and worse outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

From Baseline to the last follow up session (16 weeks)

Results posted on

2023-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Real TBS to the mPFC Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Real TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded)	Sham TBS to the mPFC Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Sham TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.	Real TBS to the MC Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Real TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded).	Sham TBS to the MC Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Sham TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.
Overall Study STARTED	13	6	13	6
Overall Study COMPLETED	9	5	10	5
Overall Study NOT COMPLETED	4	1	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real TBS to the mPFC n=13 Participants Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Real TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded)	Sham TBS to the mPFC n=6 Participants Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Sham TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.	Real TBS to the MC n=13 Participants Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Real TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded).	Sham TBS to the MC n=6 Participants Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Sham TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.	Total n=38 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 13 • n=5 Participants	62 years STANDARD_DEVIATION 9 • n=7 Participants	63 years STANDARD_DEVIATION 7 • n=5 Participants	59 years STANDARD_DEVIATION 8 • n=4 Participants	60 years STANDARD_DEVIATION 10 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	30 Participants n=21 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	0 Participants n=21 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	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Baseline to the last follow up session (16 weeks)

Outcome measures

Outcome measures
Measure	Real TBS to the mPFC n=9 Participants Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Real TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded)	Sham TBS to the mPFC n=5 Participants Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Sham TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.	Real TBS to the MC n=10 Participants Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Real TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded).	Sham TBS to the MC n=5 Participants Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Sham TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.
Changes in Patient Reported Pain and Discomfort	47 percent change from baseline Standard Deviation 190	13 percent change from baseline Standard Deviation 32	-30 percent change from baseline Standard Deviation 39	-18 percent change from baseline Standard Deviation 28

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 4 and a half months

Based on pilot data, the investigators expect an interaction between treatment (Real DLPFC or MPFC TMS vs. Sham) and time (Before vs. After rTMS) on reported painfulness using a quantitative sensory testing technique determines the sensation and pain thresholds of warm temperatures. Painfulness ratings will be assessed and reported through the duration of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 4 and a half months

Evaluating real and sham iTBS to the motor cortex vs. real and sham iTBS to the medial prefrontal cortex and how the brain activity attenuates the baseline brain response to pain (Pain Network activity). It is predicted that regardless of which site, TBS in general will dampen pain and the engagement of the Pain Network when compared to baseline activity before any treatment (as measured through BOLD signal).

Outcome measures

Outcome data not reported

Adverse Events

Real TBS to the mPFC

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham TBS to the mPFC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Real TBS to the MC

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham TBS to the MC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Real TBS to the mPFC n=13 participants at risk Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Real TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded)	Sham TBS to the mPFC n=6 participants at risk Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the medial prefrontal cortex (mPFC) over the course of the treatment and maintenance phase of the study Sham TBS to the mPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.	Real TBS to the MC n=13 participants at risk Two sessions of real Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Real TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded).	Sham TBS to the MC n=6 participants at risk Two sessions of sham Theta Burst Stimulation (TBS) will be delivered to the somatomotor cortex (MC) over the course of the treatment and maintenance phase of the study Sham TBS to the MC: This will be delivered with the Magventure Magpro system (double blinded). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the coil.
General disorders Headache	38.5% 5/13 • Number of events 14 • From enrollment until final follow-up session, 16 weeks.	16.7% 1/6 • Number of events 2 • From enrollment until final follow-up session, 16 weeks.	15.4% 2/13 • Number of events 4 • From enrollment until final follow-up session, 16 weeks.	16.7% 1/6 • Number of events 3 • From enrollment until final follow-up session, 16 weeks.

Additional Information

Merideth Addicott, PhD

Wake Forest University School of Medicine

Phone: 336-716-7792

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place