Trial Outcomes & Findings for Molecular and Functional PET-fMRI Measures of Analgesia in Migraine (NCT NCT01970943)

NCT ID: NCT01970943

Last Updated: 2019-05-17

Results Overview

This study will investigate how placebo may reduce experimental pain induced by contact heat. Patients rate heat stimulus intensity on a 0-10 scale, where 0 is no pain, and 10 is most intense pain possible. Data is reported to the placebo condition. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'most intense pain possible'. The patient is asked to mark his pain level on the line between the two endpoints.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

1 day

Results posted on

2019-05-17

Participant Flow

The study design was indeed crossover, but the cross-over was done immediately on the same day. In other words, participants were either scheduled to receive no intervention, and then placed placebo approximately 2 hours later to allow for washout. Or placed placebo first, and then no intervention approximately 2 hours later. No actual drug used.

Participant milestones

Participant milestones
Measure	No Intervention First, Then Placebo PET-fMRI investigation on healthy subjects and patients with migraine. No drug conditioning and then placebo saline injection.	Placebo First, Then No Intervention PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injected followed by no drug conditioning.
Overall Study STARTED	11	12
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Intervention n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition and placebo (saline IV injection)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	No Intervention n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition and placebo saline injection.	Placebo n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injection followed by no drug condition.
Visual Analogue Scale (VAS) 0-10 Pain Rating	4.3 units on a scale Standard Deviation 2.4	7.2 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 1 day

Population: 9 migraine subjects

We imaged the subjects under an MRI scan. All data was collected on a Siemens 3 Tesla MR scanner using a PETcompatible eight-channel head coil. Structural T1 weighted MPRAGE Functional scans were preprocessed using slice timing correction, realignment, normalization, and smoothing (8 mm FWHM Gaussian filter), using SPM12. In each condition (placebo \& no drug) subjects underwent four sets of pain anticipation at high and low temperatures (somatosensory control condition). The stimuli were modeled as boxcar time series, with additional regressors for temperature ramp-up, ramp-down, pain rating sequence, and six motion regressors.data were collected for each of the two PET-MR scans. Contrasts analyzed included pain anticipation. The values for the 8 sets of anticipation, for both the migraine and the healthy group are combined

Outcome measures

Outcome measures
Measure	No Intervention n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition and placebo saline injection.	Placebo n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injection followed by no drug condition.
Pain Anticipation fMRI BOLD Signal	0.5665 arbitrary units Standard Deviation 0.8318	1.1743 arbitrary units Standard Deviation 0.8447

SECONDARY outcome

Timeframe: 1 day

Population: 9 migraine subjects

We imaged the subjects under an MRI scan. All data was collected on a Siemens 3 Tesla MR scanner using a PETcompatible eight-channel head coil. Structural T1 weighted MPRAGE Functional scans were preprocessed using slice timing correction, realignment, normalization, and smoothing (8 mm FWHM Gaussian filter), using SPM12. In each condition (placebo \& no drug) subjects underwent four sets of pain stimulation at high and low temperatures (somatosensory control condition). The stimuli were modeled as boxcar time series, with additional regressors for temperature ramp-up, ramp-down, pain rating sequence, and six motion regressors.data were collected for each of the two PET-MR scans. Contrasts analyzed included pain stimulation. The values for the 8 sets of stimulation, for both the migraine and the healthy group are combined

Outcome measures

Outcome measures
Measure	No Intervention n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition and placebo saline injection.	Placebo n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injection followed by no drug condition.
Pain Stimulation fMRI BOLD Signal	.5745 arbitrary units Standard Deviation .8224	1.1537 arbitrary units Standard Deviation .8326

SECONDARY outcome

Timeframe: 1 day

Population: 9 migraine subjects

We sought to find if endogenous opioid levels and endogenous opioid release induced by placebo administration differentiates between the no intervention first, then placebo group compared to the placebo first, then no intervention group in migraine patients.

Outcome measures

Outcome measures
Measure	No Intervention n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition and placebo saline injection.	Placebo n=23 Participants PET-fMRI investigation on healthy subjects and patients with migraine. Placebo saline injection followed by no drug condition.
PET Diprenorphine	1.251 standard uptake value Standard Deviation 0.259	1.214 standard uptake value Standard Deviation 0.175

Adverse Events

No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr David Borsook, study PI

Massachusetts General Hospital

Phone: 6172817135

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place