tACS for Neuropathic Pain Management After SCI

NCT ID: NCT06029075

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

"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.

Group Type EXPERIMENTAL

tACS Sham

Intervention Type DEVICE

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

tACS 10Hz

Intervention Type DEVICE

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

tACS 20Hz

Intervention Type DEVICE

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

"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.

Group Type EXPERIMENTAL

tACS Sham

Intervention Type DEVICE

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

tACS 10Hz

Intervention Type DEVICE

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

tACS 20Hz

Intervention Type DEVICE

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

"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.

Group Type EXPERIMENTAL

tACS Sham

Intervention Type DEVICE

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

tACS 10Hz

Intervention Type DEVICE

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

tACS 20Hz

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tACS Sham

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

Intervention Type DEVICE

tACS 10Hz

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

Intervention Type DEVICE

tACS 20Hz

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sheng Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sheng Li, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sheng Li, MD, Ph.D

Role: CONTACT

(713) 797-7125

Shengai Li, MS

Role: CONTACT

713-797-7561

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sheng Li, MD, PhD

Role: primary

713-797-7125

Shengai Li, MS

Role: backup

713-797-7561

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-22-0046 (Experiment 2)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.