Chronic PaintDCSNCT05863494
Transcranial Direct Current Stimulation and Chronic Pain
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Chronic Pain, run by University of Arizona at 1 site in United States.
Trial summary
This clinical trial uses transcranial direct current stimulation (tDCS) using the patented tKIWI system to safely reduce self-reported chronic pain with little to no side effects to improve our understanding and ability to accurately diagnose pain disorders which would facilitate the development of pharmacologic and… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-79 years old
- Gender: Any
- Ethnicity: Any
- Chronic pain (> 3-months); No current use of nonprescription opioids (< 1 month); Able and willing to comply with scheduled visits and other study-related procedures to complete the study; Willing and able to give informed consent.
Who cannot join
- Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime)); mental retardation.
- History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
- Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
- Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
- Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
- Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
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- Female subject who is pregnant.
- Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; Note that translation of the proposed ACT activity into English has not been validated and that we cannot be confident that they would be accurately translated and validated.
- Minors
- Older than 79 years old
- last use >24 months
- history of EEG or any electrical implant (i.e. pacemaker)
- history of Parkinson's, diagnosis of bipolar, schizophrenia/schizo-affective d/o, OCD, epilepsy, alzheimers
- taking antipsychotic drugs
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85719
Allison J Huff, DHEd, 520-626-4839, allison7@arizona.edu
Leena Idris, BS, (520)247-4415, idris1@email.arizona.edu
About this study
Official title: Toward Personalized Treatment of Chronic Pain Using Transcranial Direct Current Stimulation Paired With Deep Learning
This clinical trial uses transcranial direct current stimulation (tDCS) using the patented tKIWI system to safely reduce self-reported chronic pain with little to no side effects to improve our understanding and ability to accurately diagnose pain disorders which would facilitate the development of pharmacologic and non-pharmacologic treatment modalities using deep learning architecture built into the tKIWI.
Read the detailed description
Pain is a severe and growing problem in the United States with more than 116 million Americans suffering from chronic pain and more than $635 billion is spent annually on pain and its related healthcare costs. Additionally, opioid addiction has become a national crisis with nearly 50,000 deaths every year as a result of opioid-involved overdoses and nearly $78.5 billion spent annually on opioid misuse and addiction. Currently available treatments for pain, namely opioid analgesics, have limited effectiveness and can lead to a significant number of side effects and complications including dependence, pharmacodynamic tolerance, sedation, gastrointestinal issues, respiratory depression, immunosuppression, and hormonal changes. Effectively treating pain requires an accurate assessment of pain, however current methods of diagnosing and evaluating pain depend on subjective self-reporting including the use of visual and numerical pain scales. The subjective nature of describing pain makes it virtually impossible to quantify and therefore difficult to treat and monitor. To overcome this subjectivity, through a non-invasive neuromodulation technique called transcranial direct current stimulation (tDCS) and deep learning, pain can be measured objectively using electroencephalograph (EEG) to assess and personalize treatment. The overarching goal of this project is to apply transcranial direct current stimulation (tDCS) as an alternative to opioids for the reduction in chronic pain. The investigator's long-term goal is to use these data to analyze EEG signals and generate personalized tDCS treatment in real time.
- Conditions
- Chronic Pain
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Transcranial Direct Current Stimulation (tDCS) sham
- Keywords
- chronic pain, transcranial direct current stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called tKIWI, ni2o
TDCS is a non-invasive brain stimulation that uses electrical currents to stimulate specific areas of the brain. A constant, low-intensity current passes through two to four electrodes, which can be placed on various locations on the head, to modulate neuronal activity. tDCS can administer anodal and cathodal stimulation to excite (depolarization) or inhibit (hyperpolarization) neuronal activity, respectively. Using low-amplitude direct currents applied via scalp electrodes to alter cortical excitability is not a novel concept. This non-pharmacological approach has held promise for decades as a way to treat a plethora of neurological and psychiatric disorders. Although tDCS is not currently FDA-approved it is considered a non-significant-risk therapy with no record of serious adverse effects.
Transcranial Direct Current Stimulation (tDCS) shamDevice
TDCS is a non-invasive brain stimulation that uses electrical currents to stimulate specific areas of the brain. A constant, low-intensity current passes through two to four electrodes, which can be placed on various locations on the head, to modulate neuronal activity. tDCS can administer anodal and cathodal stimulation to excite (depolarization) or inhibit (hyperpolarization) neuronal activity, respectively. Using low-amplitude direct currents applied via scalp electrodes to alter cortical excitability is not a novel concept. This non-pharmacological approach has held promise for decades as a way to treat a plethora of neurological and psychiatric disorders.
The sham group will receive 1 minute from 0.0mA to no more than 0.5mA at the initiation of the treatment after which the current will be turned off. This is to maintain a blind trial. 0.5mA is negligible current, but mimics treatment with an initial small tingle.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | For visits 1-5 (tDCS treatment visits), the investigators will start with 0.5mA ramping up to 0.75mA for 5 minutes. Followed by a brief (8 sec) EEG recording. Then, the investigators will apply .75mA to 1mA for 5 minutes. This will also be followed by 8 second EEG recording. The final application of current will be 1mA to 1.75mA for 10 minutes followed again by 8 second EEG recording. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham | Sham comparator | For visits 1-5 (tDCS treatment visits),The sham group will receive 1 minute from 0.0mA to no more than 0.5mA at the initiation of the treatment after which the current will be turned off. They will still proceed with the full 20 minutes as does the treatment group but no current will be further applied as indicated in the treatment group. They will still receive EEG readings at the indicated 8 seconds after "current" is applied but will not receive the current. This is to maintain a blind trial. 0.5mA is negligible current but mimics treatment with an initial small tingle. Receives: Device: Transcranial Direct Current Stimulation (tDCS) sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the impact of tDCS on pain in chronic pain participants using pain perception scale
The investigators will compare the baseline pain perception scale results of subjects in treatment and placebo arms to pain perception scales results on the final day of the treatment and again one week later, enabling investigators to determine any short-term change or durable change to pain. The scale is the Wong-Baker FACES® Pain Rating Scale "Based on the visual representations and descriptions below, please rate your chronic pain on a scale from 1 (no pain) to 10 (worst possible pain)." The measurement is done using the ranking of 1 to 10 in pain, adding up to the total of the response and the larger numbers indicate higher pain levels with no units.
Measured: 14 months
Determine the impact of tDCS on the self-reported reduction in opioid use, or the desire for opioid use.
The investigators will compare baseline opioid use and desire to use opioids to final visit in both treatment and sham arms. The measurement will be a comparison in the self-reported survey "Medication for Pain Management Survey". This survey has questions such as, "My need for using opioid pain medication is less than before I participated in this study", and "My desire to use opioid pain medication is less than before I participated in this study". These are answered using "yes, no, or unknown".
Measured: 14 months
Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing blood pressure
The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is blood pressure (mmHg).
Measured: 14 months
Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate
The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is heart rate (bpm).
Measured: 14 months
Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate
The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is temperature (degrees C).
Measured: 14 months
Secondary outcomes (2)
Compare changes in brain waves during tDCS treatment sessions in the treatment (tDCS) and placebo (sham) arms.
This aim will be achieved by capturing EEG readings of the entire brain for subjects in each treatment arm at baseline, during the treatment phase, and at final study visit 1 week post treatment. The EEG showcases brain wave activity in microvolts (mV).
Measured: 14 months
Compare the tolerability of the tDCS system (tKIWI) versus placebo (sham)
We will achieve this aim by evaluating the results of a questionnaire after each treatment session and after the final study visit, enabling us to capture reported discomfort. The questions state "Please report any side-effects as well as the intensity and persistence of reported side-effects you may have experienced during the application of transcranial direct current stimulation (tDCS).", and evaluate if there is itching, tingling, burning, redness, and headaches. If there is a symptom then the participant will note the intensity as "very, a little, or barely"
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of the tDCS using the tKIWI device on chronic pain. The participant will be randomly assigned to the treatment (tx) or sham/placebo group. Up to 40 participants will be recruited and randomly placed in either the treatment or the sham group. The randomization ratio is 1:1. Each participant has an equal chance of being assigned to each condition and each participant will be assigned to a condition independently of the other participants. The sample is small (20 each group), so in order to ensure random assignment, we will assign a unique number to every participant of the study's sample. Then, we will use a lottery method to randomly assign each number to the control or experimental group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- ni20
- Responsible party
- Principal investigator, Allison J Huff Macpherson, University of Arizona
- Investigators
- Allison J Huff, DHEd, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863494
- Sponsor's protocol ID
- STUDY00001896
- Acronym
- tDCS
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results will not be shared with participants. They will be shared via publication in peer-reviewed journals. The data-sharing agreement with our industry partner will use deidentified data from tKIWi to strengthen the algorithm and patented machine learning. The data will be stored on an encrypted SD card and shared with our industry partner via upload to HIPAA Compliant Google Workspace. * Publish findings in an academic journal * Present findings internally and at conference * Publish biomarkers data in academic journal
Publications
Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
PubMed 22553896National Institute on Drug Abuse. Overdose Death Rates. 29 Jan 2021 [cited 12 May 2021]. Available: https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates
Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
PubMed 27623005Hedegaard H, Minino AM, Warner M. Urban-rural Differences in Drug Overdose Death Rates, by Sex, Age, and Type of Drugs Involved, 2017. NCHS Data Brief. 2019 Aug;(345):1-8.
PubMed 31442197Porreca F, Ossipov MH. Nausea and vomiting side effects with opioid analgesics during treatment of chronic pain: mechanisms, implications, and management options. Pain Med. 2009 May-Jun;10(4):654-62. doi: 10.1111/j.1526-4637.2009.00583.x. Epub 2009 Mar 19.
PubMed 19302436Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635Crofford LJ. Chronic Pain: Where the Body Meets the Brain. Trans Am Clin Climatol Assoc. 2015;126:167-83.
PubMed 26330672Yang S, Chang MC. Chronic Pain: Structural and Functional Changes in Brain Structures and Associated Negative Affective States. Int J Mol Sci. 2019 Jun 26;20(13):3130. doi: 10.3390/ijms20133130.
PubMed 31248061Kim D, Chae Y, Park HJ, Lee IS. Effects of Chronic Pain Treatment on Altered Functional and Metabolic Activities in the Brain: A Systematic Review and Meta-Analysis of Functional Neuroimaging Studies. Front Neurosci. 2021 Jul 5;15:684926. doi: 10.3389/fnins.2021.684926. eCollection 2021.
PubMed 34290582Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008.
PubMed 18256259de Williams AC, Davies HTO, Chadury Y. Simple pain rating scales hide complex idiosyncratic meanings. Pain. 2000 Apr;85(3):457-463. doi: 10.1016/S0304-3959(99)00299-7.
PubMed 10781919McGovern MP, Carroll KM. Evidence-based practices for substance use disorders. Psychiatr Clin North Am. 2003 Dec;26(4):991-1010. doi: 10.1016/s0193-953x(03)00073-x.
PubMed 14711132Reese ED, Kane LF, Paquette CE, Frohlich F, Daughters SB. Lost in Translation: the Gap Between Neurobiological Mechanisms and Psychosocial Treatment Research for Substance Use Disorders. Curr Addict Rep. 2021 Sep;8(3):440-451. doi: 10.1007/s40429-021-00382-8. Epub 2021 Jul 7.
PubMed 40406375van der Stel J. Precision in Addiction Care: Does It Make a Difference? Yale J Biol Med. 2015 Nov 24;88(4):415-22. eCollection 2015 Dec.
PubMed 26604867Vanderah TW, Suenaga NM, Ossipov MH, Malan TP Jr, Lai J, Porreca F. Tonic descending facilitation from the rostral ventromedial medulla mediates opioid-induced abnormal pain and antinociceptive tolerance. J Neurosci. 2001 Jan 1;21(1):279-86. doi: 10.1523/JNEUROSCI.21-01-00279.2001.
PubMed 11150345
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Personalized Treatment of Chronic Pain Using Transcranial Direct Current Stimulation Paired With Deep Learning
- ClinicalTrials.gov ID
- NCT05863494
- Acronym / sponsor ID
- tDCS / STUDY00001896
- Conditions
- Chronic Pain
- Keywords
- chronic pain, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- ni20
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial uses transcranial direct current stimulation (tDCS) using the patented tKIWI system to safely reduce self-reported chronic pain with little to no side effects to improve our understanding and ability to accurately diagnose pain disorders which would facilitate the development of pharmacologic and non-pharmacologic treatment modalities using deep learning architecture built into the tKIWI.
Detailed description
Pain is a severe and growing problem in the United States with more than 116 million Americans suffering from chronic pain and more than $635 billion is spent annually on pain and its related healthcare costs. Additionally, opioid addiction has become a national crisis with nearly 50,000 deaths every year as a result of opioid-involved overdoses and nearly $78.5 billion spent annually on opioid misuse and addiction. Currently available treatments for pain, namely opioid analgesics, have limited effectiveness and can lead to a significant number of side effects and complications including dependence, pharmacodynamic tolerance, sedation, gastrointestinal issues, respiratory depression, immunosuppression, and hormonal changes. Effectively treating pain requires an accurate assessment of pain, however current methods of diagnosing and evaluating pain depend on subjective self-reporting including the use of visual and numerical pain scales. The subjective nature of describing pain makes it virtually impossible to quantify and therefore difficult to treat and monitor. To overcome this subjectivity, through a non-invasive neuromodulation technique called transcranial direct current stimulation (tDCS) and deep learning, pain can be measured objectively using electroencephalograph (EEG) to assess and personalize treatment. The overarching goal of this project is to apply transcranial direct current stimulation (tDCS) as an alternative to opioids for the reduction in chronic pain. The investigator's long-term goal is to use these data to analyze EEG signals and generate personalized tDCS treatment in real time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of the tDCS using the tKIWI device on chronic pain. The participant will be randomly assigned to the treatment (tx) or sham/placebo group. Up to 40 participants will be recruited and randomly placed in either the treatment or the sham group. The randomization ratio is 1:1. Each participant has an equal chance of being assigned to each condition and each participant will be assigned to a condition independently of the other participants. The sample is small (20 each group), so in order to ensure random assignment, we will assign a unique number to every participant of the study's sample. Then, we will use a lottery method to randomly assign each number to the control or experimental group.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)For visits 1-5 (tDCS treatment visits), the investigators will start with 0.5mA ramping up to 0.75mA for 5 minutes. Followed by a brief (8 sec) EEG recording. Then, the investigators will apply .75mA to 1mA for 5 minutes. This will also be followed by 8 second EEG recording. The final application of current will be 1mA to 1.75mA for 10 minutes followed again by 8 second EEG recording. |
| Sham | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS) shamFor visits 1-5 (tDCS treatment visits),The sham group will receive 1 minute from 0.0mA to no more than 0.5mA at the initiation of the treatment after which the current will be turned off. They will still proceed with the full 20 minutes as does the treatment group but no current will be further applied as indicated in the treatment group. They will still receive EEG readings at the indicated 8 seconds after "current" is applied but will not receive the current. This is to maintain a blind trial. 0.5mA is negligible current but mimics treatment with an initial small tingle. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-79 years old
- Gender: Any
- Ethnicity: Any
- Chronic pain (> 3-months); No current use of nonprescription opioids (< 1 month); Able and willing to comply with scheduled visits and other study-related procedures to complete the study; Willing and able to give informed consent.
Key exclusion criteria (14 listed)
- Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime)); mental retardation.
- History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
- Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
- Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
- Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: tKIWI, ni2oTDCS is a non-invasive brain stimulation that uses electrical currents to stimulate specific areas of the brain. A constant, low-intensity current passes through two to four electrodes, which can be placed on various locations on the head, to modulate neuronal activity. tDCS can administer anodal and cathodal stimulation to excite (depolarization) or inhibit (hyperpolarization) neuronal activity, respectively. Using low-amplitude direct currents applied via scalp electrodes to alter cortical excitability is not a novel concept. This non-pharmacological approach has held promise for decades as a way to treat a plethora of neurological and psychiatric disorders. Although tDCS is not currently FDA-approved it is considered a non-significant-risk therapy with no record of serious adverse effects. | Device | Treatment |
| Transcranial Direct Current Stimulation (tDCS) shamTDCS is a non-invasive brain stimulation that uses electrical currents to stimulate specific areas of the brain. A constant, low-intensity current passes through two to four electrodes, which can be placed on various locations on the head, to modulate neuronal activity. tDCS can administer anodal and cathodal stimulation to excite (depolarization) or inhibit (hyperpolarization) neuronal activity, respectively. Using low-amplitude direct currents applied via scalp electrodes to alter cortical excitability is not a novel concept. This non-pharmacological approach has held promise for decades as a way to treat a plethora of neurological and psychiatric disorders. The sham group will receive 1 minute from 0.0mA to no more than 0.5mA at the initiation of the treatment after which the current will be turned off. This is to maintain a blind trial. 0.5mA is negligible current, but mimics treatment with an initial small tingle. | Device | Sham |
Primary outcome
Determine the impact of tDCS on pain in chronic pain participants using pain perception scale
Time frame: 14 months
The investigators will compare the baseline pain perception scale results of subjects in treatment and placebo arms to pain perception scales results on the final day of the treatment and again one week later, enabling investigators to determine any short-term change or durable change to pain. The scale is the Wong-Baker FACES® Pain Rating Scale "Based on the visual representations and descriptions below, please rate your chronic pain on a scale from 1 (no pain) to 10 (worst possible pain)." The measurement is done using the ranking of 1 to 10 in pain, adding up to the total of the response and the larger numbers indicate higher pain levels with no units.
Determine the impact of tDCS on the self-reported reduction in opioid use, or the desire for opioid use.
Time frame: 14 months
The investigators will compare baseline opioid use and desire to use opioids to final visit in both treatment and sham arms. The measurement will be a comparison in the self-reported survey "Medication for Pain Management Survey". This survey has questions such as, "My need for using opioid pain medication is less than before I participated in this study", and "My desire to use opioid pain medication is less than before I participated in this study". These are answered using "yes, no, or unknown".
Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing blood pressure
Time frame: 14 months
The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is blood pressure (mmHg).
Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate
Time frame: 14 months
The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is heart rate (bpm).
Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate
Time frame: 14 months
The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is temperature (degrees C).
2 secondary outcomes
Compare changes in brain waves during tDCS treatment sessions in the treatment (tDCS) and placebo (sham) arms.
Time frame: 14 months
Compare the tolerability of the tDCS system (tKIWI) versus placebo (sham)
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Results publication: PubMed 22553896Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
- Results publicationNational Institute on Drug Abuse. Overdose Death Rates. 29 Jan 2021 [cited 12 May 2021]. Available: https://www.drugabuse.gov/drug-topics/trends-statistics/overdose-death-rates
- Results publication: PubMed 27623005Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
- Results publication: PubMed 31442197Hedegaard H, Minino AM, Warner M. Urban-rural Differences in Drug Overdose Death Rates, by Sex, Age, and Type of Drugs Involved, 2017. NCHS Data Brief. 2019 Aug;(345):1-8.
- Results publication: PubMed 19302436Porreca F, Ossipov MH. Nausea and vomiting side effects with opioid analgesics during treatment of chronic pain: mechanisms, implications, and management options. Pain Med. 2009 May-Jun;10(4):654-62. doi: 10.1111/j.1526-4637.2009.00583.x. Epub 2009 Mar 19.
- Results publication: PubMed 18443635Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Results publication: PubMed 26330672Crofford LJ. Chronic Pain: Where the Body Meets the Brain. Trans Am Clin Climatol Assoc. 2015;126:167-83.
- Results publication: PubMed 31248061Yang S, Chang MC. Chronic Pain: Structural and Functional Changes in Brain Structures and Associated Negative Affective States. Int J Mol Sci. 2019 Jun 26;20(13):3130. doi: 10.3390/ijms20133130.
- Results publication: PubMed 34290582Kim D, Chae Y, Park HJ, Lee IS. Effects of Chronic Pain Treatment on Altered Functional and Metabolic Activities in the Brain: A Systematic Review and Meta-Analysis of Functional Neuroimaging Studies. Front Neurosci. 2021 Jul 5;15:684926. doi: 10.3389/fnins.2021.684926. eCollection 2021.
- Results publication: PubMed 18256259Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008.
- Results publication: PubMed 10781919de Williams AC, Davies HTO, Chadury Y. Simple pain rating scales hide complex idiosyncratic meanings. Pain. 2000 Apr;85(3):457-463. doi: 10.1016/S0304-3959(99)00299-7.
- Results publication: PubMed 14711132McGovern MP, Carroll KM. Evidence-based practices for substance use disorders. Psychiatr Clin North Am. 2003 Dec;26(4):991-1010. doi: 10.1016/s0193-953x(03)00073-x.
- Individual participant dataSharing planned: Yes. Study results will not be shared with participants. They will be shared via publication in peer-reviewed journals. The data-sharing agreement with our industry partner will use deidentified data from tKIWi to strengthen the algorithm and patented machine learning. The data will be stored on an encrypted SD card and shared with our industry partner via upload to HIPAA Compliant Google Workspace. * Publish findings in an academic journal * Present findings internally and at conference * Publish biomarkers data in academic journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison J Huff, DHEd principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Chronic Pain, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allison J Huff, DHEd ((520) 626-4839, allison7@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the impact of tDCS on pain in chronic pain participants using pain perception scale (time frame: 14 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05863494, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.