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tACS for Neuropathic Pain After SCI

N/A

Waitlist Available

Led By Sheng Li, MD, Ph.D

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has neuropathic pain after traumatic spinal cord injury or amputation or brain injury

Patient is between 18 to 75 years of age

Must not have

Patient has asthma or other pulmonary disease

Patient has amputation in their arm(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change of hrv 10-15 minutes before and after the tacs intervention will be measured.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for pain relief in people with spinal cord injuries.

Who is the study for?

This trial is for individuals aged 18-75 who have neuropathic pain following a traumatic spinal cord injury, amputation, or brain injury and have been stable on oral pain medications for at least two weeks. It's not suitable for those with pacemakers, metal implants, unstable medical conditions, non-neuropathic pain like inflammation from surgery wounds, arm amputations, psychiatric disorders currently adjusting their pain meds or with substance abuse issues.

What is being tested?

The study tests the effectiveness of transcranial alternating current stimulation (tACS) in managing neuropathic pain after spinal cord injuries. Participants will receive either a sham (fake) treatment or real tACS at different frequencies (10Hz or 20Hz) to see if there's an improvement in their pain levels.

What are the potential side effects?

While the specific side effects of tACS are not detailed here, similar treatments can sometimes cause mild headaches, tingling sensations on the scalp during application, fatigue shortly after treatment sessions and discomfort due to muscle contractions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have nerve pain from a spinal cord injury, amputation, or brain injury.

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I am between 18 and 75 years old.

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I have been experiencing pain for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have asthma or another lung condition.

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I have had an amputation in one or both of my arms.

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I am unable to follow instructions or give consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change of hrv 10-15 minutes before and after the tacs intervention will be measured.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change of hrv 10-15 minutes before and after the tacs intervention will be measured.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change of hrv 10-15 minutes before and after the tacs intervention will be measured. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart rate variability (HRV) measurement

Pain scale (visual analogue scale, VAS) measurement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental orderExperimental Treatment3 Interventions

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.

Group II: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental orderExperimental Treatment3 Interventions

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.

Group III: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental orderExperimental Treatment3 Interventions

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.

0 / 6Eligibility criteria met