Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

Chronic Pain Clinical Trial

Official title:

Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03625752
• Other study ID #: STUDY20180314-2/20201584
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: May 7, 2025

Study information

• Verified date: September 2023
• Source: Case Western Reserve University
• Contact: Megan O'Neill Miller
• Phone: 216-844-4720
• Email: megan.miller3[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Other known NCT identifiers

• NCT05469074

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 7, 2025
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Able to provide informed consent to participate in the study.

2. Subjects between 40 to 80 years old.

3. Having diabetic neuropathic pain, involving at least 1 foot, with 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).

4. Having 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.

5. Must have the ability to feel pain as self-reported.

Exclusion Criteria:

1. Subject is pregnant.

2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices

3. History of alcohol or drug abuse within the past 6 months as self-reported.

4. Use of carbamazepine within the past 6 months as self-reported.

5. Suffering from severe depression (with a PHQ 9 score of = 10).

6. History of neurological disorders as self-reported.

7. History of unexplained fainting spells as self-reported.

8. History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.

9. History of neurosurgery as self-reported.

10. 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).

Related Conditions & MeSH terms

• Chronic Pain
• Diabetic Neuropathies

Intervention

Device:
• Active Comparator: Active tDCS + Active TUS
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.
• Sham
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.

Locations

Country	Name	City	State
United States	Ciro Ramos Estebanez	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	Highland Instruments, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Measured for approximately 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	N-back tests	Assesses registration and immediate recall on a scale of the number of items correctly responded to	Measured for approximately 3 months
Secondary	Electroencephalography	Investigators will measure electroencephalogram (EEG) electrical activity (EEG amplitude and EEG frequency) as function of time.	Measured for approximately 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Health Questionnaire (PHQ-9)	This questionnaire screens for depression with a score of 0 (best) to 27 (worst)	Measured for approximately 3 months
Secondary	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
Secondary	Multidimensional Pain Inventory (MPI)	This pain scale measures aspects of pain from 0 (best) to 6 (worst)	Measured for approximately 3 months
Secondary	Brief Pain Inventory-DPN	This pain scale measures aspects of pain from 0 (no pain) to 10 (worst)	Measured for approximately 3 months
Secondary	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