Noninvasive Brain Stimulation for Diabetic Neuropathic Pain
Study Details
Study Description
Brief Summary
This is an investigator-initiated study that is in the funding range for a grant from the NIH. This study is testing the possibility that non-invasive brain stimulation (ESSTim) would be superior to sham in the treatment of pain secondary to diabetic neuropathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The investigators hypothesize that Active ESStim will have a significantly improved and lasting effect compared to SHAM ESStim assessed in 40 DNP patients, 20 per group, given now for 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation given 20 min/day (total stimulations n=11) and follow-ups at 2, 4, 6, & 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active tDCS + Active TUS Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS). |
Device: Active tDCS + Active TUS
Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes.
Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes.
|
| Sham Comparator: Sham Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS). |
Device: Device: Sham
Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. 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 sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes.
|
Outcome Measures
Primary Outcome Measures
- Changes in pain as measured by the Visual Analog Scale [3 months]
The Visual Analog 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 in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.
Secondary Outcome Measures
- Changes in the Verbal Rating Scale for Pain [3 months]
The Verbal Rating Scale 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 in conjunction. with transcranial ultrasound (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.
- Changes in Conditional Pain Modulation [3 months]
Changes in Conditional Pain Modulation will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound (applied in a diagnostic mode) is effective in increasing the pain pressure threshold (e.g., pounds per square inch) in subjects with diabetic neuropathic pain where a higher number is better and a lower number is worse.
- Changes in Visual Analog Scale for Mood - Anxiety [3 months]
The Visual Analog Scale for Mood will investigate Anxiety. The Subscales is as follows: The anxiety scale will assess a patient's anxiety on a scale from 0 (not anxious) to 10 (very anxious).
- Montreal Cognitive Assessment [3 months]
The investigators will monitor the safety of transcranial direct current stimulation and transcranial ultrasound in subjects by measuring any changes in cognition. Scores range from lowest being 0 to highest being 30.
- 4-choice reaction time [3 months]
This is an attentional task that measures the time for a subject response to stimuli (in seconds) with shorter times being better.
- N-back tests [3 months]
This instrument has been used in our past brain stimulation studies and will be used to assess working memory. This is a computer-assisted test.
- Electroencephalography [3 months]
Investigators will measure electroencephalogram electrical activity (amplitude) as function of time.
- Electroencephalography [3 months]
Investigators will measure electroencephalogram electrical activity (frequency) as function of time.
- Walking test [3 months]
The investigators will measure if there are changes in the walking speed of the subject from the beginning of the study to the end
- Walking test [3 months]
The investigators will measure if there are changes in the gait asymmetry of the subject from the beginning of the study to the end
- Walking test [3 months]
The investigators will measure if there are changes in the stride length, and walking smoothness of the subject from the beginning of the study to the end
- Walking test [3 months]
The investigators will measure if there are changes in the stride length of the subject from the beginning of the study to the end
- Walking test [3 months]
The investigators will measure if there are changes in the walking smoothness of the subject from the beginning of the study to the end
- Functional reach test [3 months]
The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.
- Study 36-Item Short Form [3 months]
This is a health survey using a scale from 0 (worst) to 100 (best)
- Patient Health Questionnaire [3 months]
This questionnaire screens for depression with a score of 0 (best) to 27 (worst)
- American Pain Foundation Pain and Medication Diary [3 months]
The pain sub-scale measures pain intensity from 0 (best) to 10 (worst)
- Multidimensional Pain Inventory [3 months]
This pain scale measures aspects of pain from 0 (best) to 6 (worst)
- Brief Pain Inventory [3 months]
This pain scale measures aspects of pain from 0 (no pain) to 10 (worst)
- Adverse events [3 months]
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.
- The Visual Analog Scale for Mood - Depression [3 months]
The Visual Analog Scale for Mood will investigate Depression. The Subscales is as follows: The depression scale will assess a patient's depression on a scale from 0 (not depressed) to 10 (very depressed).
- The Visual Analog Scale for Mood - Stress [3 months]
The Visual Analog Scale for Mood will investigate Stress. The Subscales is as follows: The stress scale will assess a patient's stress on a scale from 0 (not stressed) to 10 (very stressed).
- The Visual Analog Scale for Mood - Sleep [3 months]
The Visual Analog Scale for Mood will investigate Sleepiness. The Subscales is as follows: The sleepiness scale will assess a patient's depression on a scale from 0 (not sleepy) to 10 (very sleepy).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Providing informed consent to participate in the study.
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Having diabetic neuropathic pain, involving at least 1 foot, as defined by International Association for the Study of Pain and meeting criteria detailed by the Toronto Diabetic Neuropathy Expert Group - existing pain for at least 6 months and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale.
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Pain resistant to common analgesics and medications for first line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
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Must have the ability to feel pain as self-reported.
Exclusion Criteria:
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Subject is pregnant.
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Contraindications to Electrosonic Stimulation (ESStim): metal in the head, or implanted brain medical devices.
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History of alcohol or drug abuse within the past 6 months as self-reported.
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Use of carbamazepine within the past 6 months as self-reported.
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Suffering from major depression (with a PHQ-9 score of ≥10).
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History of neurological disorders involving stroke, brain tumors, or epilepsy as self-reported (note patients will also be evaluated via EEG at baseline 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed))
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History of unexplained fainting spells as self-reported.
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History of head injury resulting in more than a momentary loss of consciousness as self-reported.
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History of neurosurgical procedures as self-reported.
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Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois Health/ University of Illinois at Chicago | Hinsdale | Illinois | United States | 60521-4902 |
| 2 | University of Illinois Health/ University Of Illinois at Chicago | Hinsdale | Illinois | United States | 60612 |
| 3 | University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit | Cleveland | Ohio | United States | 44106-1716 |
Sponsors and Collaborators
- Case Western Reserve University
- Highland Instruments, Inc.
Investigators
- Principal Investigator: Salim Hayek, MD PhD, University Hospitals Cleveland Medical Center/ Case Western Reserve University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY20201584