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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA214102 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to examine the efficacy of tDCS (transcranial direct current stimulation) for increasing exercise adherence among low active individuals with elevated depressive symptoms. The investigators expect that this project will contribute much needed knowledge about the role that tDCS can play in changing the affective experience of exercise.
Exercise adherence is a significant public health problem. Affective experiences during exercise predict long-term physical activity (PA) levels. Therefore, approaches to improving the affective experience of exercise are both important and likely to have high impact. This may be particularly true among individuals with elevated depressive symptoms due to their tendency toward more negative and less positive affect. tDCS is a noninvasive brain stimulation approach with a growing body of literature supporting its effects on cognitive and emotional processing in varied populations, including some support for those with depression. In addition, there is recent increased interest in utilizing tDCS in the context of exercise (see above) and in obesity prevention. While the effects of tDCS on behavioral and cognitive functioning are still developing, promising findings have emerged for tDCS used in repeated combination with a behavioral or cognitive intervention. Given that tDCS is relatively safe, inexpensive, and portable, individuals who struggle with enjoying exercise could be afforded a practical option for increasing and maintaining physical activity levels.
We propose to conduct a pilot randomized controlled trial of tDCS versus sham delivered 3x/week for 8 weeks in the context of a supervised aerobic exercise (AE) program among 72 low-active individuals with elevated depressive symptoms. Follow-up assessments will be conducted at end of treatment, 3, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS and Aerobic Exercise | Active Comparator | Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. |
|
| Sham tDCS and Aerobic Exercise | Sham Comparator | Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Other | Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Levels | Accelerometry-based moderate-to-vigorous physical activity (MVPA) | 8 week assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS and Aerobic Exercise | Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. |
| FG001 | Sham tDCS and Aerobic Exercise | Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS and Aerobic Exercise | Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Physical Activity Levels | Accelerometry-based moderate-to-vigorous physical activity (MVPA) | The numbers analyzed include only individuals that provided valid wear-time data on the primary outcome measure, using accelerometry. Specifically, only participants that provided 3 days of 8 hours/day valid wear time were included in the analysis of the primary outcome. | Posted | Mean | Standard Deviation | minutes per day | 8 week assessment |
|
6 months
It does not differ from clinicaltrials.gov definitions
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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 and Aerobic Exercise | Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. tDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Inpatient Hospitalization | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana M. Abrantes, Ph.D. | Butler Hospital | 4014556440 | Ana_Abrantes@Brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 21, 2018 | Jan 2, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Sham tDCS | Other | Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. |
|
| Aerobic Exercise (AE) | Behavioral | Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. |
|
| BG001 | Sham tDCS and Aerobic Exercise | Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Depressive Symptoms | Baseline depressive symptoms were collected using the Center for Epidemiological Studies--Depression (CES-D) measure. The range of scores is 0 to 60. Scores above 15 indicate clinical depression. Higher scores indicate higher levels of depression. | Mean | Standard Deviation | units on a scale |
|
| Minutes of Moderate-to-Vigorous Physical Activity (MVPA) | Mean | Standard Deviation | minutes per day |
|
| OG001 | Sham tDCS and Aerobic Exercise | Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. |
|
|
|
| 0 |
| 25 |
| 4 |
| 25 |
| 2 |
| 25 |
| EG001 | Sham tDCS and Aerobic Exercise | Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks. Sham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks. Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. | 0 | 26 | 0 | 26 | 1 | 26 |
| Medical Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Medical Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Medical Hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| knee injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |