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Trial Outcomes & Findings for Effect of Theta Burst Stimulation on Alcohol Cue Reactivity (NCT NCT04223154)

NCT ID: NCT04223154

Last Updated: 2023-05-19

Results Overview

This outcome measure rates the change in k-value, or the delay discounting value of alcohol compared at baseline vs 1 hour after the intervention. Delay discounting is the tendency to place less value on rewards that are delayed in time. K typically falls between 0.0 and 0.5, with smaller values indicating a lack of discounting and a preference for delayed rewards, and higher values indicating stronger discounting and a preference for immediate rewards.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Baseline to 1 hour after the intervention

Results posted on

2023-05-19

Participant Flow

Participant milestones

Participant milestones
Measure
Real TBS to the dlPFC
One session of real intermittent Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) Real iTBS to the dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
Sham TBS to the dlPFC
One session of sham Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) Sham iTBS to the dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
Overall Study
STARTED
8
3
Overall Study
COMPLETED
8
3
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Theta Burst Stimulation on Alcohol Cue Reactivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Real TBS to the dlPFC
n=8 Participants
One session of real intermittent Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) Real iTBS to the dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
Sham TBS to the dlPFC
n=3 Participants
One session of sham Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) Sham iTBS to the dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
Total
n=11 Participants
Total of all reporting groups
Age, Continuous
56.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
40 years
STANDARD_DEVIATION 5.3 • n=7 Participants
52 years
STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
1 Participants
n=7 Participants
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 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
0 Participants
n=7 Participants
0 Participants
n=5 Participants
AUDIT score
19.4 units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
21 units on a scale
STANDARD_DEVIATION 4 • n=7 Participants
19.8 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 1 hour after the intervention

Population: Intent to treat population. There were no missing data.

This outcome measure rates the change in k-value, or the delay discounting value of alcohol compared at baseline vs 1 hour after the intervention. Delay discounting is the tendency to place less value on rewards that are delayed in time. K typically falls between 0.0 and 0.5, with smaller values indicating a lack of discounting and a preference for delayed rewards, and higher values indicating stronger discounting and a preference for immediate rewards.

Outcome measures

Outcome measures
Measure
Real TBS to the dlPFC
n=8 Participants
One session of real intermittent Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) Real iTBS to the dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
Sham TBS to the dlPFC
n=3 Participants
One session of sham Theta Burst Stimulation (TBS) will be delivered to the left dorsolateral prefrontal cortex (dlPFC) Sham iTBS to the dlPFC: This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
Behavioral Outcomes: Change in the k-Value, a Measure of Delay Discounting of Alcohol
-0.12 Change in k-value
Standard Deviation 0.27
-7.42 Change in k-value
Standard Deviation 14.5

POST_HOC outcome

Timeframe: 1 hour after the intervention

This will be measured using the blood oxygen level dependent signal in the prefrontal cortex

Outcome measures

Outcome data not reported

Adverse Events

Real TBS to the dlPFC

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham TBS to the dlPFC

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 A. Hanlon, Ph.D.

Wake Forest University School of medicine

Phone: 336-716-5465

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place