Transcranial Direct Current Stimulation and Chronic Pain

NCT05863494 | Unknown

• 1 other identifier: STUDY00001896
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (5)

• 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.

  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".

  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).

  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).

  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).

  14 months

Secondary Outcomes (2)

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

  14 months

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

  14 months

Study Arms (2)

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.

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.

Device: Transcranial Direct Current Stimulation (tDCS) sham

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Also known as: tKIWI, ni2o

Treatment

Transcranial Direct Current Stimulation (tDCS) sham DEVICE

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.

Sham

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• ni20: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

Related Publications (53)

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MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Allison J Huff, DHEd

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison J Huff, DHEd

CONTACT

(520) 626-4839; allison7@arizona.edu

Leena Idris, BS

CONTACT

(520) 2474415; idris1@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family and Community Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 18, 2023
• Study Start: June 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (1)