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tACS for Neuropathic Pain Management After SCI

Primary Purpose

Neuropathic Pain Management

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tACS Sham
tACS 10Hz
tACS 20Hz
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain Management focused on measuring tACS, Neuropathic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion/exclusion criteria for SCI subjects Inclusion criteria: A patient who has neuropathic pain after traumatic spinal cord injury or amputation or brain injury; has chronic pain, >3 months; is between 18 to 75 years of age; 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 are currently adjusting oral pain medications for their neuropathic pain; have pain, but not neuropathic, e.g., from inflammation at the incision wound of the residual limb or neuroma; have a pacemaker metal implants or supplemental oxygen; have amputation in their arm(s); fail to have a motor contraction in the arm muscles with TMS; are not able to follow commands, or to give consent; have asthma or other pulmonary disease; are not medically stable; have preexisting psychiatric disorders; alcohol or drug abuse.

Sites / Locations

  • The University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

"tACS Sham, tACS 10Hz, tACS 20Hz" experimental order

"HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order

"HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order

Arm Description

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. 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. 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.

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. 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. 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.

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. 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. 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.

Outcomes

Primary Outcome Measures

Pain scale (visual analogue scale, VAS) measurement
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."
Heart rate variability (HRV) measurement
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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
August 31, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT06029075
Brief Title
tACS for Neuropathic Pain Management After SCI
Official Title
tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2027 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain Management
Keywords
tACS, Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"tACS Sham, tACS 10Hz, tACS 20Hz" experimental order
Arm Type
Experimental
Arm Description
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. 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. 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.
Arm Title
"HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order
Arm Type
Experimental
Arm Description
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. 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. 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.
Arm Title
"HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order
Arm Type
Experimental
Arm Description
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. 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. 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.
Intervention Type
Device
Intervention Name(s)
tACS Sham
Intervention Description
Sham tACS will applied to the brain through the scalp for 20 minutes.
Intervention Type
Device
Intervention Name(s)
tACS 10Hz
Intervention Description
10Hz tACS will applied to the brain through the scalp for 20 minutes.
Intervention Type
Device
Intervention Name(s)
tACS 20Hz
Intervention Description
20Hz tACS will applied to the brain through the scalp for 20 minutes.
Primary Outcome Measure Information:
Title
Pain scale (visual analogue scale, VAS) measurement
Description
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."
Time Frame
Change of VAS 5 minutes before and after the tACS intervention will be measured.
Title
Heart rate variability (HRV) measurement
Description
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
Time Frame
Change of HRV 10-15 minutes before and after the tACS intervention will be measured.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion/exclusion criteria for SCI subjects Inclusion criteria: A patient who has neuropathic pain after traumatic spinal cord injury or amputation or brain injury; has chronic pain, >3 months; is between 18 to 75 years of age; 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 are currently adjusting oral pain medications for their neuropathic pain; have pain, but not neuropathic, e.g., from inflammation at the incision wound of the residual limb or neuroma; have a pacemaker metal implants or supplemental oxygen; have amputation in their arm(s); fail to have a motor contraction in the arm muscles with TMS; are not able to follow commands, or to give consent; have asthma or other pulmonary disease; are not medically stable; have preexisting psychiatric disorders; alcohol or drug abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Li, MD, Ph.D
Phone
(713) 797-7125
Email
sheng.li@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shengai Li, MS
Phone
713-797-7561
Email
shengai.li@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng Li, MD, Ph.D
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Li, MD, PhD
Phone
713-797-7125
Email
sheng.li@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Shengai Li, MS
Phone
713-797-7561
Email
shengai.li@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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tACS for Neuropathic Pain Management After SCI

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