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tACS for Neuropathic Pain Management After SCI

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ClinicalTrials.gov Identifier: NCT06029075
Recruitment Status : Not yet recruiting
First Posted : September 8, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Sheng Li, The University of Texas Health Science Center, Houston

Study Description
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Brief Summary:
The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for neuropathic pain management in people after spinal cord injury.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Management Device: tACS Sham Device: tACS 10Hz Device: tACS 20Hz Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
Estimated Study Start Date : September 1, 2024
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental order
  1. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
  2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  3. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
 Device: tACS Sham
Sham tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 10Hz
10Hz tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 20Hz
20Hz tACS will applied to the brain through the scalp for 20 minutes.
Experimental: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order
  1. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
 Device: tACS Sham
Sham tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 10Hz
10Hz tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 20Hz
20Hz tACS will applied to the brain through the scalp for 20 minutes.
Experimental: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order
  1. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.
  2. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.
  3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.
 Device: tACS Sham
Sham tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 10Hz
10Hz tACS will applied to the brain through the scalp for 20 minutes.

Device: tACS 20Hz
20Hz tACS will applied to the brain through the scalp for 20 minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Pain scale (visual analogue scale, VAS) measurement [ Time Frame: Change of VAS 5 minutes before and after the tACS intervention will be measured. ]
    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  2. Heart rate variability (HRV) measurement [ Time Frame: Change of HRV 10-15 minutes before and after the tACS intervention will be measured. ]
    Heart rate variability (HRV) is the fluctuation in the time intervals between adjacent heartbeats (1). HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system (ANS) processes. HRV will be used as a surrogate assessment for autonomic nerve system


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion/exclusion criteria for SCI subjects

Inclusion criteria: A patient who

  1. has neuropathic pain after traumatic spinal cord injury or amputation or brain injury;
  2. has chronic pain, >3 months;
  3. is between 18 to 75 years of age;
  4. is stable on oral pain medications at least two weeks. Patients are allowed to continue their pain medications, i.e., no change in pain medications.

NOTE: we plan to begin the study with the spinal cord injury (SCI) subject population as a cohort first, then expand to other subject populations

Exclusion criteria: Patients will be excluded if they

  1. are currently adjusting oral pain medications for their neuropathic pain;
  2. have pain, but not neuropathic, e.g., from inflammation at the incision wound of the residual limb or neuroma;
  3. have a pacemaker metal implants or supplemental oxygen;
  4. have amputation in their arm(s);
  5. fail to have a motor contraction in the arm muscles with TMS;
  6. are not able to follow commands, or to give consent;
  7. have asthma or other pulmonary disease;
  8. are not medically stable;
  9. have preexisting psychiatric disorders;
  10. alcohol or drug abuse.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029075


Contacts
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Contact: Sheng Li, MD, Ph.D (713) 797-7125 sheng.li@uth.tmc.edu
Contact: Shengai Li, MS 713-797-7561 shengai.li@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center
Houston, Texas, United States, 77030
Contact: Sheng Li, MD, PhD    713-797-7125    sheng.li@uth.tmc.edu   
Contact: Shengai Li, MS    713-797-7561    shengai.li@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Sheng Li, MD, Ph.D The University of Texas Health Science Center, Houston
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sheng Li, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT06029075    
Other Study ID Numbers: HSC-MS-22-0046 (Experiment 2)
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sheng Li, The University of Texas Health Science Center, Houston:
tACS
Neuropathic Pain
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations