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

NCT ID: NCT05113563

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2024-01-17

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.

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

open label

this is an open label study

Group Type: OTHER

Transcranial Electric Stimulation Therapy

Intervention Type: DEVICE

TEST is a form of brain stimulation.

Interventions

Transcranial Electric Stimulation Therapy

TEST is a form of brain stimulation.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Diana Martinez

Clinical Professor in Psychaitry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

1051 Riverside Drive

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

7978

Identifier Type: -

Identifier Source: org_study_id