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Transcranial Direct Current Stimulation and Chronic Pain (tDCS)

Primary Purpose

Chronic Pain

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation (tDCS) sham

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, transcranial direct current stimulation

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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

Sites / Locations

University of ArizonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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".

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).

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).

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).

Secondary Outcome Measures

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).

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"

Full Information

NCT ID

NCT05863494

First Posted

April 10, 2023

Last Updated

May 15, 2023

Sponsor

University of Arizona

Collaborators

ni20

1. Study Identification

Unique Protocol Identification Number

NCT05863494

Brief Title

Transcranial Direct Current Stimulation and Chronic Pain

Acronym

tDCS

Official Title

Toward Personalized Treatment of Chronic Pain Using Transcranial Direct Current Stimulation Paired With Deep Learning

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2023 (Anticipated)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

Collaborators

ni20

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

chronic pain, transcranial direct current stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigator

Masking Description

Participants will be assigned a random unique number which will be randomly correlated with either treatment group or sham group. The participant will not have access to see in the redcap system which arm they are in. 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. The investigator who is not involved in assigning groups will receive data with de-identification.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS)

Other Intervention Name(s)

tKIWI, ni2o

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Transcranial Direct Current Stimulation (tDCS) sham

Intervention Description

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.

Primary Outcome Measure Information:

Title

Determine the impact of tDCS on pain in chronic pain participants using pain perception scale

Description

Time Frame

14 months

Title

Determine the impact of tDCS on the self-reported reduction in opioid use, or the desire for opioid use.

Description

Time Frame

14 months

Title

Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing blood pressure

Description

The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is blood pressure (mmHg).

Time Frame

14 months

Title

Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate

Description

The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is heart rate (bpm).

Time Frame

14 months

Title

Compare the safety of the tDCS system (tKIWI) versus placebo (sham) utilizing heart rate

Description

The investigators will achieve this aim by monitoring subjects' vitals during the entire session of each visit. The measurement is temperature (degrees C).

Time Frame

14 months

Secondary Outcome Measure Information:

Title

Compare changes in brain waves during tDCS treatment sessions in the treatment (tDCS) and placebo (sham) arms.

Description

Time Frame

14 months

Title

Compare the tolerability of the tDCS system (tKIWI) versus placebo (sham)

Description

Time Frame

14 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Allison J Huff, DHEd

Phone

(520) 626-4839

allison7@arizona.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Leena Idris, BS

Phone

(520) 2474415

idris1@arizona.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allison J Huff, DHEd

Organizational Affiliation

University of Arizona

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arizona

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Allison J Huff, DHEd

Phone

520-626-4839

allison7@arizona.edu

First Name & Middle Initial & Last Name & Degree

Leena Idris, BS

Phone

(520)247-4415

idris1@email.arizona.edu

First Name & Middle Initial & Last Name & Degree

Allison J Huff, DHed

First Name & Middle Initial & Last Name & Degree

Todd Vanderah, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing Time Frame

The data will be available during month 16 of the clinical study. This will occur after the analysis of the data is performed, and the study is completed. There is no expiration on how long this information will be available.

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Transcranial Direct Current Stimulation and Chronic Pain

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