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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Transcranial Electric Stimulation Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • 1051 Riverside Drive

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Study Population

Participants with chronic pain and 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: open label; this is an open label study	Device: Transcranial Electric Stimulation Therapy; TEST is a form of brain stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Will be Assessed by the Percent of Participants Who Complete	Feasibility will be assessed by the percent of participants start study procedures and complete these	4 weeks

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): January 16, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 7978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes