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

NCT05113563 | Completed Results FDA Device

• 1 other identifier: 7978
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

open label

OTHER

this is an open label study

Device: Transcranial Electric Stimulation Therapy

Interventions

Transcranial Electric Stimulation Therapy DEVICE

TEST is a form of brain stimulation.

open label

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

1051 Riverside Drive

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Diana Martinez
• Organization: NYSPI

dm437@cumc.columbia.edu

646-771-7774

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Psychaitry

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: January 2, 2023
• Primary Completion: January 16, 2024
• Study Completion: January 17, 2024
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)