NCT06029075

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Sep 2025Mar 2028

First Submitted

Initial submission to the registry

May 10, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

May 10, 2023

Last Update Submit

February 20, 2025

Conditions

Neuropathic Pain Management

Keywords

tACSNeuropathic Pain

Outcome Measures

Primary Outcomes (2)

  • 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."

    Change of VAS 5 minutes before and after the tACS intervention will be measured.

  • 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

    Change of HRV 10-15 minutes before and after the tACS intervention will be measured.

Study Arms (3)

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

EXPERIMENTAL

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 ShamDevice: tACS 10HzDevice: tACS 20Hz

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

EXPERIMENTAL

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 ShamDevice: tACS 10HzDevice: tACS 20Hz

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

EXPERIMENTAL

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 ShamDevice: tACS 10HzDevice: tACS 20Hz

Interventions

tACS ShamDEVICE

Sham tACS will applied to the brain through the scalp for 20 minutes.

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

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

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

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

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sheng Li, MD, Ph.D

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Li, MD, Ph.D

CONTACT

(713) 797-7125sheng.li@uth.tmc.edu

Shengai Li, MS

CONTACT

713-797-7561shengai.li@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

September 8, 2023

Study Start

September 1, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)