Investigation of TEST (Transcranial Electric Stimulation Therapy) for Chronic Pain

Chronic Pain Clinical Trial

Official title:

Investigation of TEST (Transcranial Electric Stimulation Therapy) for Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113563
• Other study ID #: 7978
• Status: Recruiting
• Start date: January 2, 2023
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal in this study is to investigate TEST (Transcranial Electric Stimulation Therapy) for chronic pain. It requires an inpatient stay on our research unit of about a month. The study is designed to address the cognitive and emotional aspects of chronic pain and other conditions that often accompany this disorder, such as major depression or drug use.

Description:

This project proposes to investigate the feasibility of TEST in subjects with chronic pain. This will be an open-label study where subjects (n=12) are administered 8-10 sessions of TEST over 4 weeks. Measurements of pain, mood, and memory will be obtained before and after the sessions. The hypothesis is that TEST will be feasible and tolerable in this population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2027
• Est. primary completion date: November 2026
• Gender: All
• Age group: 22 Years to 60 Years

Eligibility

Inclusion Criteria:

1. adults (ages 22 to 60) who understand all procedures and have the ability to provide informed consent, with a score on the Mini-Mental Status Exam of at least 24;

2. participants experiencing chronic pain, with ongoing pain symptoms, and score on the Brief Pain Inventory of > 5 on question #3 (which asks about maximal pain in the past 24 hours) or > 5 on question #5 (which asks about average pain in the past 24 hours);

3. a diagnosis of chronic postoperative pain, low back pain, musculoskeletal pain, fibromyalgia, visceral pain or neuropathic pain, including complex regional pain syndrome or peripheral neuropathy;

4. no significant changes in pain medications for at least one month prior to study entry.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Transcranial Electric Stimulation Therapy
TEST is a form of brain stimulation.

Locations

Country	Name	City	State
United States	1051 Riverside Drive	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility will be assessed by the percent of participants who complete the study	Feasibility will be assessed by the percent of participants who complete the study	4 weeks