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| Name | Class |
|---|---|
| China Medical University Hospital | OTHER |
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This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and VAS will be obtained after 3-4 hours of each stimulation.
This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days. An initial eligibility screening within Day -14. Pt admitted to hospital on Day 1. The lead implantation is conducted on Day 2, and the 1st treatment starts after anesthesia recovery (Day 2 T1). If VAS >4 at 4 hours after the 1st treatment, the 2nd treatment will be conducted. VAS will be acquired 4 hours after the 2nd treatment. On Day 3, physical examination and vital signs will be collected. If VAS >4, the 3rd treatment will be provided. One hour after the 3rd treatment, the device will be removed and an X-ray will be taken. Three hours after the removal, VAS will be collected and then the patient will be discharged. VAS will be estimated by phone call on Day 4, and the patient will return to OPD for follow up examination on Day 5. The trial is completed on Day 5 visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrahigh Frequency Stimulation | Experimental | Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GiMer Medical MN 1000 External Stimulator | Device | Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) | Number of Participants with Adverse Events and Serious Adverse Events | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Measured by Visual Analog Scale (VAS) | VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS. | 4 days |
| Incidence of Paresthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrahigh Frequency Stimulation | Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrahigh Frequency Stimulation | Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range. |
| 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 | Safety of Ultrahigh Frequency Treatment: Adverse Event (AE) and Serious AE (SAE) | Number of Participants with Adverse Events and Serious Adverse Events | Posted | Count of Participants | Participants | 5 days |
|
|
Trial duration (4 days)
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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 | Ultrahigh Frequency Stimulation | Patients with chronic lower limb pain will be treated with ultrahigh frequency stimulation via lead around DRG. GiMer Medical MN 1000 External Stimulator: Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yeong-Ray Wen (Department of Anaesthesia) | China Medical University Hospital (in Taiwan) | +886 4 2205-2121 | yray.wen@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2017 | Jun 5, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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|
If patients feel tingling during stimulation?
| 2 days |
| Change in Pain Medication Consumption | Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline | 5 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Pain Measured by Visual Analog Scale (VAS) | VAS: 0 (no pain) to 10 (max pain). Change in pain as a result of ultrahigh frequency DRG stimulation, as measured by VAS score compare to baseline VAS. | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| Secondary | Incidence of Paresthesia | If patients feel tingling during stimulation? | Posted | Count of Participants | Participants | 2 days |
|
|
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| Secondary | Change in Pain Medication Consumption | Decrease in pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline | Posted | Count of Participants | Participants | 5 days |
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|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 5 |
| 10 |
| procedural headache | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Increase blood pressure | Investigations | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |