Trial Outcomes & Findings for Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder (NCT NCT04495673)

Last Updated: 2025-07-10

Results Overview

Safety was defined as the prevalence of Serious Adverse Events for the study. Subjects were monitored for Serious Adverse Events from date of first intervention session until the final follow-up visit (2 months post-intevention). Subjects were monitored using the Symptom Rating Questionnaire (SRQ), Medication/Medical Update Interview, and medical chart review. Serious Adverse Events were defined as: Death, life threatening incidents, hospitalizations (initial or prolonged), disability or permanent damage, congenital anomaly or birth defect, or an event that required intervention to prevent permanent impairment or damage. Mean and standard deviation of Serious Adverse Events was recorded across groups. A lower number indicates fewer Serious Adverse Events.

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

2months post-intervention

Results posted on

2025-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	tDCS With Cognitive Training DLPFC stimulation with tDCS with simultaneous cognitive training Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) Cognitive Training: Executive functioning tasks	Sham tDCS With Cognitive Training Sham tDCS with simultaneous cognitive training Sham Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) Cognitive Training: Executive functioning tasks
Overall Study STARTED	5	4
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tDCS With Cognitive Training n=5 Participants DLPFC stimulation with tDCS with simultaneous cognitive training Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) Cognitive Training: Executive functioning tasks	Sham tDCS With Cognitive Training n=4 Participants Sham tDCS with simultaneous cognitive training Sham Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) Cognitive Training: Executive functioning tasks	Total n=9 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 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	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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

PRIMARY outcome

Timeframe: 2months post-intervention

Outcome measures

Outcome measures
Measure	tDCS With Cognitive Training n=3 Participants DLPFC stimulation with tDCS with simultaneous cognitive training Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) Cognitive Training: Executive functioning tasks	Sham tDCS With Cognitive Training n=2 Participants Sham tDCS with simultaneous cognitive training Sham Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) Cognitive Training: Executive functioning tasks
(A1) Average Number of Serious Adverse Events in Active and Sham Groups.	0 Number of adverse events Standard Deviation 0	0 Number of adverse events Standard Deviation 0

PRIMARY outcome

Timeframe: 1-week post-intervention

Population: Due to extreme motion artifacts preventing data acquisition, we were unable to collect minimum quantity of data necessary for the imaging analysis software to generate descriptive statistics.

Brain activation change from pre-intervention to post-intervention was planned to be compard between active tDCS and sham groups. We hypothesized that the active tDCS group will have a larger increase in brain circuit engagement than the sham group and, thus, a better outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 months post-intervention

Population: Small numbers of subjects due to COVID-19 pandemic, insufficient N for interpreting data.

Cognitive performance change was compared between active tDCS and sham groups. Cognitive performance change was defined as improvement on the WAIS-IV Digit Span (DS). Score was calculating by subtracting the DS scaled score at baseline from the DS scaled score at 2-Month Follow Up. We hypothesized that the active tDCS group will have a larger improvement in cognitive performance than the sham group. A higher number indicates a higher impact of cognitive training and, thus, a better outcome. The DS Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two DS Scaled Scores has a range of -9 (min.) to 9 (max.)

Outcome measures

Outcome measures
Measure	tDCS With Cognitive Training n=3 Participants DLPFC stimulation with tDCS with simultaneous cognitive training Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) Cognitive Training: Executive functioning tasks	Sham tDCS With Cognitive Training n=2 Participants Sham tDCS with simultaneous cognitive training Sham Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) Cognitive Training: Executive functioning tasks
(A3) Changes in Scaled Score on Digit Span Task.	-2.7 score on a scale Standard Deviation 1.7	-1.5 score on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 2 months post-intervention

Population: Four participants who were randomized but were lost to follow-up prior to the 2 month follow up were not included in these analyses.

Relapse was defined as any illiciit drug use (whether reported by the patient or reported as a positive drug screen in study or medical records) that occurred at some point between study intervention and the final follow-up visit (2 months post-intervention). Relapse was measured with the Timeline Follow Back questionnaire, saliva drug screen at the study visit, and chart review of urine drug screens. Relapse was coded 0 (did not relapse during the study) or 1 (relapsed during the study). We hypothesized that the active tDCS group will have a lower relapse rate than the sham group. A higher number indicates a higher count of participants with a relapse.

Outcome measures

Outcome measures
Measure	tDCS With Cognitive Training n=3 Participants DLPFC stimulation with tDCS with simultaneous cognitive training Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) Cognitive Training: Executive functioning tasks	Sham tDCS With Cognitive Training n=2 Participants Sham tDCS with simultaneous cognitive training Sham Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) Cognitive Training: Executive functioning tasks
(A4) Number of Participants Who Relapsed After Intervention.	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 2-months post-intervention

"Durability of cognitive training was defined as improvement on the WAIS-IV Digit Scale Symbol/Coding (CD) test. The improvement period was measured between baseline and the study completion (2 months post-intervention). The score was calculated by subtracting the CD scaled score at baseline from the CD Scaled Score at 2-months post-intervention. A higher number indicates a higher impact on cognitive abilities, and a better outcome. The CD Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two CD Scaled Scores has a range of -9 (min.) to 9 (max.)"

Outcome measures

Outcome measures
Measure	tDCS With Cognitive Training n=3 Participants DLPFC stimulation with tDCS with simultaneous cognitive training Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) Cognitive Training: Executive functioning tasks	Sham tDCS With Cognitive Training n=2 Participants Sham tDCS with simultaneous cognitive training Sham Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) Cognitive Training: Executive functioning tasks
Changes in Scaled Score on Digit Symbol Task.	-1 score on a scale Standard Deviation 3.6	-1 score on a scale Standard Deviation 6

Adverse Events

tDCS With Cognitive Training

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham tDCS With Cognitive Training

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	tDCS With Cognitive Training n=5 participants at risk DLPFC stimulation with tDCS with simultaneous cognitive training Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) Cognitive Training: Executive functioning tasks	Sham tDCS With Cognitive Training n=4 participants at risk Sham tDCS with simultaneous cognitive training Sham Transcranial Direct Current Stimulation (tDCS): Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) Cognitive Training: Executive functioning tasks
General disorders Headache	20.0% 1/5 • Number of events 1 • 1 year	0.00% 0/4 • 1 year
Musculoskeletal and connective tissue disorders neck pain	20.0% 1/5 • Number of events 2 • 1 year	0.00% 0/4 • 1 year
General disorders tingling sensation	40.0% 2/5 • Number of events 3 • 1 year	25.0% 1/4 • Number of events 1 • 1 year
General disorders itching sensation	60.0% 3/5 • Number of events 9 • 1 year	25.0% 1/4 • Number of events 1 • 1 year
General disorders burning sensation	40.0% 2/5 • Number of events 7 • 1 year	0.00% 0/4 • 1 year
General disorders skin redness	40.0% 2/5 • Number of events 2 • 1 year	0.00% 0/4 • 1 year
General disorders sleepiness/fatigue	60.0% 3/5 • Number of events 6 • 1 year	25.0% 1/4 • Number of events 3 • 1 year
General disorders poor concentration	80.0% 4/5 • Number of events 11 • 1 year	25.0% 1/4 • Number of events 2 • 1 year
General disorders acute mood change	40.0% 2/5 • Number of events 2 • 1 year	25.0% 1/4 • Number of events 1 • 1 year
General disorders Nausea	20.0% 1/5 • Number of events 1 • 1 year	0.00% 0/4 • 1 year

Additional Information

Kelvin Lim

University of Minnesota

Phone: (612) 626-6772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place