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| Name | Class |
|---|---|
| Highland Instruments, Inc. | INDUSTRY |
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The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.
Active stimulation will be compared with compared to SHAM stimulation in DNP patients.
20 DNP patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits).
Subsequently, 40 DNP patients will be enrolled, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, & 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: Active tDCS + Active TUS | Active Comparator | Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). |
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| Sham | Sham Comparator | Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: Active tDCS + Active TUS | Device | Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain as measured by the Visual Analog Scale (VAS) | The scale will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Changes in VAS for Pain will be measured to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain. | Measured for approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Verbal Rating Scale (VRS) for Pain | The VRS for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity. Changes in VRS for Pain will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction. with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salim Hayek, MD PhD | University Hospitals Cleveland Medical Center/ Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciro Ramos Estebanez | Chicago | Illinois | 60612 | United States | ||
| University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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single-center, double-blinded, placebo controlled, randomized study.
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| Sham | Device | Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes. |
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| Measured for approximately 3 months |
| Changes in Conditional Pain Modulation | Changes in Conditional Pain Modulation (CPM) will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in increasing the pain pressure threshold in subjects with diabetic neuropathic pain. | Measured for approximately 3 months |
| Changes in Visual Analog Scalefor Mood (VAMS) | The VAS for Mood will investigate Anxiety, Depression, Stress, and Sleepiness. The Subscales are as follows: The anxiety scale will assess a patient's anxiety on a scale from 0 (not anxious) to 10 (very anxious). The depression scale will assess a patient's depression on a scale from 0 (not depressed) to 10 (very depressed). The stress scale will assess a patient's stress on a scale from 0 (not stressed) to 10 (very stressed). The sleepiness scale will assess a patient's depression on a scale from 0 (not sleepy) to 10 (very sleepy). | Measured for approximately 3 months |
| Montreal Cognitive Assessment | The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition. Scores range from lowest being 0 to highest being 30. | Measured for approximately 3 months |
| 4-choice reaction time | This is an attentional task that measures the time for a subject response to stimuli (in seconds) with shorter times being better. | Measured for approximately 3 months |
| N-back tests | Assesses registration and immediate recall on a scale of the number of items correctly responded to | Measured for approximately 3 months |
| Electroencephalography | Investigators will measure electroencephalogram (EEG) electrical activity (EEG amplitude and EEG frequency) as function of time. | Measured for approximately 3 months |
| Walking test | The investigators will measure if there are changes in the walking speed, gait asymmetry, stride length, and walking smoothness of the subject from the beginning of the study to the end | Measured for approximately 3 months |
| Functional reach test | The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study. | Measured for approximately 3 months |
| Study 36-Item Short Form (SF-36) | This is a health survey using a scale from 0 (worst) to 100 (best) | Measured for approximately 3 months |
| Patient Health Questionnaire (PHQ-9) | This questionnaire screens for depression with a score of 0 (best) to 27 (worst) | Measured for approximately 3 months |
| American Pain Foundation Pain and Medication Diary | The pain sub-scale measures pain intensity from 0 (best) to 10 (worst) | Measured for approximately 3 months |
| Multidimensional Pain Inventory (MPI) | This pain scale measures aspects of pain from 0 (best) to 6 (worst) | Measured for approximately 3 months |
| Brief Pain Inventory-DPN | This pain scale measures aspects of pain from 0 (no pain) to 10 (worst) | Measured for approximately 3 months |
| Adverse events | At each session after stimulation begins, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale (0 being best and 5 worst). The scale will also be administered at the follow-up. | Measured for approximately 3 months |
| Cleveland |
| Ohio |
| 44106-1716 |
| United States |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |