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Although the majority of older adults are aware of the compelling evidence that regular exercise is critical to the maintenance of health into old age, most do not meet recommendations for daily exercise. This lack of engagement in 'goal-directed' physical activity stems from numerous interrelated factors including lack of motivation, depressed mood, and cognitive "executive" impairments that diminish one's ability to regulate behavior over time. Intriguingly, each of these factors has been linked to the function of brain networks that include the left dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a noninvasive and safe means of modulating the excitability of specific brain regions and their connected neural networks. tDCS designed to facilitate the excitability of the left dlPFC has been shown to improve motivation, mood, and multiple aspects of executive function in healthy adults. The investigators thus hypothesize that tDCS holds promise to increase goal-directed physical activity in older adults. This project aims to conduct a pilot randomized controlled trial on the feasibility and effects of a 2-week, 10-session tDCS intervention targeting the left dlPFC, combined with behavioral intervention aimed at increases daily physical activity, on physical activity over a two-month follow-up period, in relatively sedentary older adults without overt illness or disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral intervention plus tDCS | Experimental | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex. |
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| Behavioral intervention plus sham stimulation | Active Comparator | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Device | tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Daily Step Counts From Baseline | Absolute change in averaged daily step counts from two-week baseline (first two weeks, week 1-2). The specific periods are 1) absolute change in averaged daily step counts in week 3 and 4 from baseline, 2) absolute change in averaged daily step counts at week 5 and 6, from baseline, 3) absolute change in averaged daily step counts in week 7 and 8 from baseline, and 4) absolute change in averaged daily step counts in week 9 and 10 from baseline. | Week 3-4, Week 5-6, Week 7-8, and Week 9-10. |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation - External Regulation Score | External Regulation Score was calculated from the Exercise Self-Regulation Questionnaire (SQR-E). External regulation refers to motivation based on external sources such as incentives or coercion. Introjected regulation refers to motivation from an internalized, pressuring voice that was not accepting it as one's own. The External Regulation Score ranges from 4 to 28. The higher scores mean a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Manor, PhD | Hebrew SeniorLife | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew Rehabilitation Center | Roslindale | Massachusetts | 02131 | United States |
The HSL Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants.
All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
The investigators will make the data and associated documentation available once summary data are published or otherwise made available, starting six months after publication.
The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using data only for research purposes and not to identify any particular participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. The availability of data will be advertised over the Internet through websites maintained by Hebrew SeniorLife and Harvard Medical School.
All investigators wishing to access the data will submit a brief proposal describing their research project, data needs, regulatory approvals, and mechanisms to assure patient confidentiality. Upon affirmative review by the Principal Investigator and co-investigators of this study, a data-sharing agreement will be signed and the requesting investigators will be given a working data file and appropriate documentation.
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Two participants signed the informed consent at the in-person screening but withdrew prior to the baseline assessment and were never randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Intervention Plus tDCS | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex. Transcranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort. Behavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. |
| FG001 | Behavioral Intervention Plus Sham Stimulation | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation. Sham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue. Behavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Intervention Plus tDCS | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex. Transcranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort. Behavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. |
| 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 | Change of Daily Step Counts From Baseline | Absolute change in averaged daily step counts from two-week baseline (first two weeks, week 1-2). The specific periods are 1) absolute change in averaged daily step counts in week 3 and 4 from baseline, 2) absolute change in averaged daily step counts at week 5 and 6, from baseline, 3) absolute change in averaged daily step counts in week 7 and 8 from baseline, and 4) absolute change in averaged daily step counts in week 9 and 10 from baseline. | Posted | Mean | Standard Error | Steps per day | Week 3-4, Week 5-6, Week 7-8, and Week 9-10. |
|
22 weeks
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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 | Behavioral Intervention Plus tDCS | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of transcranial direct current stimulation (tDCS) designed to increase the excitability of the left dorsolateral prefrontal cortex. Transcranial direct current stimulation (tDCS): tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort. Behavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombosis | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| On-Yee Lo | Hebrew SeniorLife | 6179715331 | AmyLo@hsl.harvrd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2022 | Oct 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2023 | Dec 13, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Sham stimulation | Device | An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue. |
|
| Behavioral intervention to increase physical activity | Behavioral | Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. |
|
| Baseline; Week 4; Week 10 |
| Timed Up-and-Go (TUG) | A common field test of mobility | Baseline; Week 4; Week 10 |
| Trail Making Test (TMT) - A | Trail making test (TMT) A is a neuropsychological test of visual attention. The test requires the patient to connect randomly positioned numbered circles in numeric order as quickly as possible. It provides information about visual search speed and speed of processing. The test reliability for TMT A is 0.82. Time is measured in seconds. | Baseline; Week 4; Week 10 |
| Trail Making Test (TMT) - B | Trail Making Test (TMT) - B is a neuropsychological test of task switching. The test requires the participants to connect the circles in numeric and alphabetic order as quickly as possible, alternating between numbers and letters. It provides information about executive function. The test reliability for TMT-B is 0.93. Time is measured in seconds. | Baseline; Week 4; Week 10 |
| Montreal Cognitive Assessment (MoCA) Total Score | Global cognitive function. The range for this test is 0-30, with higher score representing better outcome. | Baseline; Week 4; Week 10 |
| Geriatric Depression Scale (15-item) | Number of depressive symptoms. The range for this test is 0-15, with lower score representing better outcome. | Baseline; Week 4; Week 10 |
| Completion Rate for Brain Stimulation Sessions | Ten stimulation sessions were planned for each participant over two weeks. This outcome presents the percentage of the completed brain stimulation sessions. | Week 4 |
| Completion Rate for Behavior Sessions | Four bi-weekly behaviors sessions were planned for each participant over two months. This outcome presents the percentage of the completed behavior sessions. | Week 10 |
| BG001 | Behavioral Intervention Plus Sham Stimulation | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation. Sham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue. Behavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Behavioral Intervention Plus Sham Stimulation | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation. Sham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue. Behavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. |
|
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| Secondary | Motivation - External Regulation Score | External Regulation Score was calculated from the Exercise Self-Regulation Questionnaire (SQR-E). External regulation refers to motivation based on external sources such as incentives or coercion. Introjected regulation refers to motivation from an internalized, pressuring voice that was not accepting it as one's own. The External Regulation Score ranges from 4 to 28. The higher scores mean a better outcome. | Posted | Mean | Standard Error | score on a scale | Baseline; Week 4; Week 10 |
|
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| Secondary | Timed Up-and-Go (TUG) | A common field test of mobility | Posted | Mean | Standard Error | seconds | Baseline; Week 4; Week 10 |
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| Secondary | Trail Making Test (TMT) - A | Trail making test (TMT) A is a neuropsychological test of visual attention. The test requires the patient to connect randomly positioned numbered circles in numeric order as quickly as possible. It provides information about visual search speed and speed of processing. The test reliability for TMT A is 0.82. Time is measured in seconds. | Posted | Mean | Standard Error | Seconds | Baseline; Week 4; Week 10 |
|
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|
| Secondary | Trail Making Test (TMT) - B | Trail Making Test (TMT) - B is a neuropsychological test of task switching. The test requires the participants to connect the circles in numeric and alphabetic order as quickly as possible, alternating between numbers and letters. It provides information about executive function. The test reliability for TMT-B is 0.93. Time is measured in seconds. | Posted | Mean | Standard Error | Seconds | Baseline; Week 4; Week 10 |
|
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|
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| Secondary | Montreal Cognitive Assessment (MoCA) Total Score | Global cognitive function. The range for this test is 0-30, with higher score representing better outcome. | Posted | Mean | Standard Error | score on a scale | Baseline; Week 4; Week 10 |
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| Secondary | Geriatric Depression Scale (15-item) | Number of depressive symptoms. The range for this test is 0-15, with lower score representing better outcome. | Posted | Mean | Standard Error | score on a scale | Baseline; Week 4; Week 10 |
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| Secondary | Completion Rate for Brain Stimulation Sessions | Ten stimulation sessions were planned for each participant over two weeks. This outcome presents the percentage of the completed brain stimulation sessions. | Posted | Mean | Standard Error | percentage of comleted sessions | Week 4 |
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| Secondary | Completion Rate for Behavior Sessions | Four bi-weekly behaviors sessions were planned for each participant over two months. This outcome presents the percentage of the completed behavior sessions. | Posted | Mean | Standard Error | percentage of comleted sessions | Week 10 |
|
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|
| 0 |
| 16 |
| 1 |
| 16 |
| 11 |
| 16 |
| EG001 | Behavioral Intervention Plus Sham Stimulation | This intervention will consist of a two-month, personalized, goal-based counseling approach to promote physical activity. Over the first two weeks of the behavioral intervention, participants will also received 10, once-daily, 20-minute sessions of sham stimulation. Sham stimulation: An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue. Behavioral intervention to increase physical activity: Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity. | 0 | 16 | 2 | 16 | 10 | 16 |
| Peripheral T-cell lymphoma unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Mole excision | Surgical and medical procedures | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Opthalmic migraine | Nervous system disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bed bug infestation | Infections and infestations | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
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| Allergy to chemicals | Immune system disorders | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Abdominal mass | Gastrointestinal disorders | Systematic Assessment |
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| Blepharoplasty | Surgical and medical procedures | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Week 10 |
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| Week 10 |
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| Week 10 |
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| Week 10 |
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| Week 10 |
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