Chronic Pain
Conditions
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.
Interventions
DEVICETranscranial Electric Stimulation Therapy
TEST is a form of brain stimulation.
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Will be Assessed by the Percent of Participants Who Complete | 4 weeks | Feasibility will be assessed by the percent of participants start study procedures and complete these |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Group All participants received open label TEST | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Active Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 39 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number enrolled in study who completed | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
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
Time frame: 4 weeks
Population: all participants entered to study procedures
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Group | Feasibility Will be Assessed by the Percent of Participants Who Complete | 6 Participants |