Trial Outcomes & Findings for Clinical Intervention in Alcohol Use Disorder (NCT NCT02168400)

NCT ID: NCT02168400

Last Updated: 2024-06-05

Results Overview

Compared mean change in brain functional connectivity (measured at two timepoints, at pre-intervention and at post-intervention) between Active tDCS and Sham groups.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2024-06-05

Participant Flow

11 consented participants were not randomized to either study group and were excluded from the study

Participant milestones

Measure	Active tDCS Subjects that are randomly assigned to this arm will receive 10 active transcranial direct current stimulation (tDCS) sessions Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.	Sham tDCS Subjects randomly assigned to sham-tDCS (transcranial direct current stimulation) will receive very low current stimulation at beginning and end of session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
Overall Study STARTED	39	36
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Intervention in Alcohol Use Disorder

Baseline characteristics by cohort

Measure	Active tDCS n=39 Participants Subjects that are randomly assigned to this arm will receive 10 active transcranial direct current stimulation (tDCS) sessions Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.	Sham tDCS n=36 Participants Subjects randomly assigned to sham-tDCS (transcranial direct current stimulation) will receive very low current stimulation at beginning and end of session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.66 years STANDARD_DEVIATION 10.43 • n=5 Participants	43.31 years STANDARD_DEVIATION 9.95 • n=7 Participants	41.87 years STANDARD_DEVIATION 10.27 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Compared mean change in brain functional connectivity (measured at two timepoints, at pre-intervention and at post-intervention) between Active tDCS and Sham groups.

Outcome measures

Measure	Active tDCS n=31 Participants Subjects that are randomly assigned to this arm will receive 10 active transcranial direct current stimulation (tDCS) sessions Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.	Sham tDCS n=29 Participants Subjects randomly assigned to sham-tDCS (transcranial direct current stimulation) will receive very low current stimulation at beginning and end of session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
Intervention Effects on Brain Functional Connectivity	0.05 percentage of Blood Oxygenation Level De Standard Error 0.05	0.19 percentage of Blood Oxygenation Level De Standard Error 0.19

SECONDARY outcome

Timeframe: 8 months

Pearson correlation, X variable was change in functional connectivity as defined by connectivity from dorsolateral prefrontal cortex to incentive salience network, Y variable was clinical outcome as defined by length of abstinence after intervention.

Outcome measures

Measure	Active tDCS n=31 Participants Subjects that are randomly assigned to this arm will receive 10 active transcranial direct current stimulation (tDCS) sessions Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.	Sham tDCS n=29 Participants Subjects randomly assigned to sham-tDCS (transcranial direct current stimulation) will receive very low current stimulation at beginning and end of session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
Correlation Between Functional Connectivity Change and Clinical Outcome (Length of Abstinence)	0.03 correlation coefficient Standard Error 0.07	0.16 correlation coefficient Standard Error 0.2

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham tDCS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active tDCS n=39 participants at risk Subjects that are randomly assigned to this arm will receive 10 active transcranial direct current stimulation (tDCS) sessions Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.	Sham tDCS n=36 participants at risk Subjects randomly assigned to sham-tDCS (transcranial direct current stimulation) will receive very low current stimulation at beginning and end of session, mimicking the feeling of current stimulation in the scalp, but not reaching levels that will stimulate brain function. Transcranial Direct Current Stimulation (tDCS): tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
General disorders Hair loss (not associated with study, MD identified hair loss was due to malnutrition)	0.00% 0/39 • 2 weeks	2.8% 1/36 • Number of events 1 • 2 weeks
General disorders Mood changes (not associated with research study, participant had prexisting mood disorder)	0.00% 0/39 • 2 weeks	2.8% 1/36 • Number of events 1 • 2 weeks

Additional Information

Jazmin Camchong

University of Minnesota

Phone: (612) 625-3330

Email: camch002@umn.edu

Results disclosure agreements

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