NCT05631548

Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder (Pilot Study)

Completed NA Results posted Last updated 31 January 2024

What this trial tests

NA trial testing iTBS to dmPFC in Cocaine Use Disorder in 6 participants. Completed in 2 August 2023.

Timeline

23 February 2023

Primary endpoint
2 August 2023

2 August 2023

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	6
Start date	23 February 2023
Primary completion	2 August 2023
Estimated completion	2 August 2023
Sites	1 location across United States

Drugs / interventions tested

• iTBS to dmPFC
• Sham iTBS

Conditions studied

• Cocaine Use Disorder — all drugs for Cocaine Use Disorder →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 18 to 60, any sex, with Cocaine Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG Primary · Baseline (before iTBS session)

The Doors Task will be used to elicit the Reward Potential (RewP) component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down. The amplitude of the RewP in microvolts in response to feedback is reported.

RewP Amplitude with Win

Group	Value	95% CI
iTBS to dmPFC	-1.09	± 1.95
Sham iTBS	0.61	± 1.80

RewP Amplitude with Loss

Group	Value	95% CI
iTBS to dmPFC	-0.23	± 2.15
Sham iTBS	0.12	± 1.75

Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG Primary · Immediately after iTBS session

The Doors Task will be used to elicit the Reward Potential (RewP) component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up (win) or if they did not find the prize by a red arrow pointing down (loss). The amplitude of the RewP in microvolts in response to feedback is reported.

RewP Amplitude with Win

Group	Value	95% CI
iTBS to dmPFC	-1.10	± 1.54
Sham iTBS	0.21	± 1.76

RewP Amplitude with Loss

Group	Value	95% CI
iTBS to dmPFC	-1.30	± 1.05
Sham iTBS	0.02	± 1.37

Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG Primary · Baseline (before iTBS session)

The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.

LPP Amplitude with Pleasant Images

Group	Value	95% CI
iTBS to dmPFC	1.10	± 1.40
Sham iTBS	0.37	± 1.85

LPP Amplitude with Unpleasant Images

Group	Value	95% CI
iTBS to dmPFC	1.01	± 2.04
Sham iTBS	0.40	± 2.55

LPP Amplitude with Cocaine Images

Group	Value	95% CI
iTBS to dmPFC	.61	± 1.49
Sham iTBS	0.46	± 1.81

LPP Amplitude with Neutral Images

Group	Value	95% CI
iTBS to dmPFC	-0.35	± 1.51
Sham iTBS	-0.95	± 2.23

Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG Primary · Immediately after iTBS session

The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.

LPP Amplitude with Pleasant Images

Group	Value	95% CI
iTBS to dmPFC	.66	± 1.48
Sham iTBS	.19	± 1.78

LPP Amplitude with Unpleasant Images

Group	Value	95% CI
iTBS to dmPFC	1.11	± 1.73
Sham iTBS	.78	± 1.67

LPP Amplitude with Cocaine Images

Group	Value	95% CI
iTBS to dmPFC	1.02	± 1.31
Sham iTBS	.43	± .43

LPP Amplitude with Neutral Images

Group	Value	95% CI
iTBS to dmPFC	-0.28	± 1.21
Sham iTBS	-0.0000929	± 1.39

Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS) Secondary · Baseline(before iTBS session)

The first question (intensity of craving) will be used and is measured from 0(none, not at all) to 100(a great deal), higher number indicating more craving.

Group	Value	95% CI
iTBS to dmPFC	41	± 39.08
Sham iTBS	31.2	± 38.55

Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS) Secondary · Immediately after iTBS session

The first question (intensity of craving) will be used and is measured from 0(none, not at all) to 100(a great deal), higher number indicating more craving.

Group	Value	95% CI
iTBS to dmPFC	33.8	± 37.81
Sham iTBS	18	± 26.39

Pain as Assessed by the Visual Analog Scale (VAS) Secondary · Baseline(before iTBS session)

This is scored from 0(no pain) to 10 (worst pain), higher score indicating greater pain.

Group	Value	95% CI
iTBS to dmPFC	0.6	± 1.2
Sham iTBS	0.2	± 0.4

Pain as Assessed by the Visual Analog Scale (VAS) Secondary · Immediately after iTBS session

This is scored from 0(no pain) to 10 (worst pain), higher score indicating greater pain.

Group	Value	95% CI
iTBS to dmPFC	2	± 3.52
Sham iTBS	1.6	± 1.74

Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA) Secondary · Baseline(before iTBS session)

Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

Group	Value	95% CI
iTBS to dmPFC	23	± 4.05
Sham iTBS	22.8	± 4.96

Cognitive Function as Assessed by the The Montreal Cognitive Assessment (MoCA) Secondary · Immediately after iTBS session

Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

Group	Value	95% CI
iTBS to dmPFC	22.4	± 3.01
Sham iTBS	25	± 2.76

Adverse events — posted to ClinicalTrials.gov

Time frame: from baseline until study completion (i.e., 2 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

iTBS to dmPFC

Serious: 0/5 (0%)

Deaths: 0/5

Sham iTBS

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (6 terms — click to expand)

Reaction	System	iTBS to dmPFC	Sham iTBS
Scalp Discomfort	General disorders	—	—
Headache	General disorders	—	—
Neck Pain	General disorders	—	—
Muscle Spasm	General disorders	—	—
Light-Headed	General disorders	—	—
Tingling	General disorders	—	—

Data from ClinicalTrials.gov NCT05631548 adverse events section.

Sponsor's own description

The purpose of this study is to assess the effects of active intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal cortex (dmPFC) on electroencephalogram (EEG) measures of reward sensitivity and cue reactivity and cocaine craving in cocaine users

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.