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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DA048508-01 | U.S. NIH Grant/Contract | View source |
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Did not reach N of participants needed
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcrancial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have successfully maintained abstinence for extended periods of time (7 years). This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease substance use probability in addiction (e.g. opioid use disorder). The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder. The overall objective of this proposal is to enhance functional connectivity between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce substance use rates in opioid use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS with Cognitive Training | Experimental | DLPFC stimulation with tDCS with simultaneous cognitive training |
|
| Sham tDCS with Cognitive Training | Active Comparator | Sham tDCS with simultaneous cognitive training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex) |
| Measure | Description | Time Frame |
|---|---|---|
| (A1) Average Number of Serious Adverse Events in Active and Sham Groups. | 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. | 2months post-intervention |
| (A2) Activation Levels in Brain Circuits in Active and Sham Groups. | 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. | 1-week post-intervention |
| (A3) Changes in Scaled Score on Digit Span Task. | 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.) | 2 months post-intervention |
| (A4) Number of Participants Who Relapsed After Intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Scaled Score on Digit Symbol Task. | "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.)" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelvin Lim, MD | University of Minnesota | Principal Investigator |
| Jazmin Camchong, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2022 |
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| Sham Transcranial Direct Current Stimulation (tDCS) | Device | Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS) |
|
| Cognitive Training | Behavioral | Executive functioning tasks |
|
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.
| 2 months post-intervention |
| 2-months post-intervention |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | (A1) Average Number of Serious Adverse Events in Active and Sham Groups. | 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. | Posted | Mean | Standard Deviation | Number of adverse events | 2months post-intervention |
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| Primary | (A2) Activation Levels in Brain Circuits in Active and Sham Groups. | 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. | 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. | Posted | 1-week post-intervention |
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| Primary | (A3) Changes in Scaled Score on Digit Span Task. | 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.) | Small numbers of subjects due to COVID-19 pandemic, insufficient N for interpreting data. | Posted | Mean | Standard Deviation | score on a scale | 2 months post-intervention |
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| Primary | (A4) Number of Participants Who Relapsed After Intervention. | 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. | Four participants who were randomized but were lost to follow-up prior to the 2 month follow up were not included in these analyses. | Posted | Count of Participants | Participants | 2 months post-intervention |
| |||||||||||||||||||||||||||||||
| Secondary | Changes in Scaled Score on Digit Symbol Task. | "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.)" | Posted | Mean | Standard Deviation | score on a scale | 2-months post-intervention |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 5 | 0 | 5 | 4 | 5 |
| EG001 | 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 | 0 | 4 | 0 | 4 | 1 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
| ||
| neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| tingling sensation | General disorders | Systematic Assessment |
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| itching sensation | General disorders | Systematic Assessment |
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| burning sensation | General disorders | Systematic Assessment |
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| skin redness | General disorders | Systematic Assessment |
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| sleepiness/fatigue | General disorders | Systematic Assessment |
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| poor concentration | General disorders | Systematic Assessment |
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| acute mood change | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelvin Lim | University of Minnesota | (612) 626-6772 | kolim@umn.edu |
| May 30, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2022 | May 30, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D006556 | Heroin Dependence |
| D009021 | Morphine Dependence |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
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