Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Other | this is an open label study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Electric Stimulation Therapy | Device | TEST is a form of brain stimulation. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1051 Riverside Drive | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Group | All participants received open label TEST |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Group | All participants received open label TEST |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | all participants entered to study procedures | Posted | Count of Participants | Participants | 4 weeks |
|
|
1 month
Definition was not different from clinical trials.gov
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Group | All participants received open label TEST | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| participant experienced symptoms from stopping medication (not a study procedure) | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Martinez | NYSPI | 646-771-7774 | dm437@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2024 | Mar 7, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number enrolled in study who completed | Count of Participants | Participants |
|
|
| 6 |
| 1 |
| 6 |
| 0 |
| 6 |
The participant abruptly stopped a medications and experience unusual paresthesias. This was not part of the study procedures, occurred during the follow up, and was not study related.
|
| participant experienced fatigue and depressed mood after taking medication (not a study procedure) | Psychiatric disorders | SNOMED CT | Systematic Assessment | During the follow up (after all study interventions completed) a participant attended an appointment with her physician and was prescribed an off label medication. She experienced fatigue and depressed mood from this. The event was not study related. |
|
Not provided
Not provided