Mobile CBT + tDCS for Chronic Pain after Bone Sarcoma

Overseen By Tara Brinkman, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Limb amputation, Seizures, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

68 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help childhood cancer survivors who have chronic pain by using a special therapy app and a device that sends mild electrical currents to the brain. The therapy app is designed to be culturally sensitive for better effectiveness. The study will test if this combined approach can improve pain management in these patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Mobile CBT + tDCS for Chronic Pain after Bone Sarcoma?

Research shows that transcranial direct current stimulation (tDCS) can help reduce chronic pain by modulating brain activity, as seen in studies with phantom limb pain and other chronic pain conditions. This suggests that tDCS might also be beneficial for managing chronic pain after bone sarcoma. ^{1 2 3 4 5}

Is Mobile CBT + tDCS safe for humans?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe for humans as it is a non-invasive brain stimulation technique. Studies have used it for various pain conditions, and it is often compared to sham (inactive) treatments to ensure safety. ^{6 7 8 9 10}

How does the treatment Mobile CBT + tDCS for chronic pain after bone sarcoma differ from other treatments?

Mobile CBT + tDCS is unique because it combines cognitive behavioral therapy (CBT), which helps change negative thought patterns, with transcranial direct current stimulation (tDCS), a non-invasive method that uses mild electrical currents to modulate brain activity. This combination targets both the psychological and neurological aspects of chronic pain, offering a novel approach compared to traditional pain management methods that often focus solely on medication or physical therapy. ^{1 2 4 5 11}

Research Team

Tara Brinkman, PHD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for non-Hispanic Black and Hispanic survivors of pediatric bone sarcoma, aged 10-17 years, who are at least one year post-treatment. They must experience chronic pain that affects their daily life. Adults can participate if they're a survivor or parent of a survivor, over 18 years old.

Inclusion Criteria

I am an adult Hispanic or non-Hispanic Black who survived childhood cancer or the parent of one.

I am a 10-17 year-old survivor of childhood cancer, at least one year post-treatment, experiencing chronic pain for more than 3 months.

I am a 10-17 year old sarcoma survivor, at least one year post-treatment, experiencing weekly pain that affects my daily life.

Exclusion Criteria

Adults/Adolescents: Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Feasibility study: Limb amputation, History of seizures or other neurological disorders, Implanted medical device or metal in the head, Serious comorbid psychiatric condition, Current substance abuse, History of development delay or significant cognitive impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cultural Adaptation

Participants attend virtual meetings and focus groups to provide feedback for culturally adapting the mobile CBT program

4 weeks

Multiple virtual meetings

Treatment

Participants receive culturally adapted mobile CBT and undergo either active or sham tDCS twice a week

6 weeks

12 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Treatment Details

Interventions

• Cognitive Behavior Therapy
• Placebo Administration
• Transcranial Direct Current Stimulation

Trial Overview The study is testing a mobile Cognitive Behavior Therapy (CBT) program adapted for cultural relevance, combined with either real or sham Transcranial Direct Current Stimulation (tDCS). The goal is to see if this combination helps manage chronic pain in adolescent cancer survivors.

Participant Groups

Group I: Interview Experimental Treatment 1 Intervention

Participants attend virtual meetings and virtual focus groups during the cultural adaptation phase. Feedback is collected and analyzed to develop the finalized adaptation.

Group II: Arm I (mobile CBT + active tDCS) Experimental Treatment 3 Interventions

Participants receive mobile CBT and undergo active tDCS to the dorsolateral prefrontal cortex (DLPFC) over 20 minutes twice a week for 6 weeks.

Group III: Arm II (mobile CBT + sham tDCS) Placebo Group 3 Interventions

Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks.

Cognitive Behavior Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders
• Post-traumatic stress disorder

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain management
• Anxiety disorders
• Depressive disorders

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Cerebellar transcranial direct current stimulation (ctDCS) effectively reduced paroxysmal pain and non-painful phantom limb sensations in 14 upper limb amputees, indicating its potential as a treatment for phantom limb pain.

The study showed that anodal ctDCS significantly dampened the amplitudes of laser-evoked potentials, suggesting it modulates nociceptive processing in the brain, although it did not affect phantom limb or stump pain compared to sham treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebellar Transcranial Direct Current Stimulation (ctDCS) Ameliorates Phantom Limb Pain and Non-painful Phantom Limb Sensations. Bocci, T., De Carolis, G., Ferrucci, R., et al.[2020]

Transcranial direct current stimulation (tDCS) applied to the motor cortex significantly reduces phantom limb pain (PLP) in amputees, with effects lasting from hours to months depending on treatment frequency.

The review included six studies, indicating that while tDCS effectively alleviates PLP intensity, it does not appear to impact phantom limb sensations or psychiatric symptoms, suggesting a need for different treatment approaches for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in the management of phantom limb pain: a systematic review of randomized controlled trials. Navarro-López, V., Del-Valle-Gratacós, M., Fernández-Vázquez, D., et al.[2023]

In a study involving 112 amputees, transcranial direct current stimulation (tDCS) significantly reduced phantom limb pain compared to sham treatment, indicating its potential as an effective therapy.

Mirror therapy did not show any additional benefits or changes in motor cortex plasticity, suggesting that tDCS alone may be a more promising treatment for managing phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined and Alone Transcranial Motor Cortex Stimulation and Mirror Therapy in Phantom Limb Pain: A Randomized Factorial Trial. Gunduz, ME., Pacheco-Barrios, K., Bonin Pinto, C., et al.[2023]

Anodal transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC) resulted in lower pain intensity ratings during acute painful stimuli compared to cathodal tDCS, indicating a potential effect on the affective aspect of pain.

While the study did not find significant differences in pain tolerance or endurance between the two stimulation types, the results suggest that tDCS may influence how pain is perceived emotionally, warranting further investigation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation (tDCS) Targeting Left Dorsolateral Prefrontal Cortex Modulates Task-Induced Acute Pain in Healthy Volunteers. Mariano, TY., Van't Wout, M., Garnaat, SL., et al.[2018]

Five consecutive days of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex significantly improved pain ratings in patients with chronic pain, with effects lasting three to four weeks post-treatment.

The study showed that anodal tDCS decreased intracortical inhibition, indicating enhanced cortical excitability, and no severe adverse effects were reported, suggesting it is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. Antal, A., Terney, D., Kühnl, S., et al.[2022]

Anodal transcranial direct current stimulation (a-tDCS) applied to the primary motor cortex significantly increases sensory and pain thresholds in healthy individuals, with effect sizes of 22.19% and 19.28%, respectively.

In patients with chronic pain, a-tDCS applied to the primary motor cortex and dorsolateral prefrontal cortex resulted in a significant reduction in pain levels, with an average decrease in pain scores of 14.9% and 19.3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. Vaseghi, B., Zoghi, M., Jaberzadeh, S.[2022]

Transcranial direct-current stimulation (tDCS) significantly reduced both mechanical and thermal hyperalgesia in a rat model of orofacial inflammatory pain, showing effectiveness in pain management up to 7 days post-treatment.

The treatment with tDCS led to increased levels of neurotrophic factors (BDNF and NGF) and anti-inflammatory cytokines (IL-6 and IL-10) in the brainstem, suggesting a mechanism of action that involves modulation of neuroplasticity and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. Scarabelot, VL., de Oliveira, C., Medeiros, LF., et al.[2019]

Transcranial Direct Current Stimulation (tDCS) is a non-invasive technique that can potentially reduce chronic pain by altering brain activity, but the evidence from five randomized controlled trials is not conclusive.

While some studies reported significant pain reduction with tDCS, the overall results varied widely among different patient groups, indicating a need for further research with larger, more defined populations before tDCS can be recommended as a treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation for chronic pain]. Fagerlund, AJ., Bystad, MK., Aslaksen, PM.[2019]

This randomized control trial involves 84 participants and aims to assess the efficacy of transcranial direct current stimulation (tDCS) as an adjunctive treatment for chronic pain, focusing on improving pain tolerance and subjective pain experiences.

Active tDCS, which delivers a 2mA current to specific areas of the brain, is being tested against a sham treatment over 10 sessions, highlighting its potential as a non-invasive option to enhance the effectiveness of existing non-opioid pain management therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management. Janice Jimenez-Torres, G., Weinstein, BL., Walker, CR., et al.[2018]

In a study of 62 lung cancer patients undergoing thoracotomy, transcranial direct current stimulation (tDCS) significantly reduced cumulative morphine consumption in the first 120 hours post-surgery compared to sham stimulation, indicating its potential efficacy in managing acute postoperative pain.

On postoperative day 5, patients receiving tDCS reported lower pain scores and less pain interference with cough, suggesting that tDCS can improve pain management shortly after surgery, although no long-term benefits were observed one year later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation Combined With Patient-Controlled Intravenous Morphine Analgesia on Analgesic Use and Post-Thoracotomy Pain. A Prospective, Randomized, Double-Blind, Sham-Controlled, Proof-of-Concept Clinical Trial. Stamenkovic, DM., Mladenovic, K., Rancic, N., et al.[2022]

In a study involving 16 chronic pain patients, transcutaneous spinal Direct Current Stimulation (tsDCS) significantly reduced pain perception as measured by the Visual Analog Scale (VAS) and the Neuropathic Pain Symptom Inventory (NPSI) after treatment and at follow-up, indicating its potential efficacy as a pain management therapy.

The results showed that tsDCS not only decreased subjective pain scores but also correlated with measurable changes in reflex responses, suggesting that tsDCS may effectively modulate the body's nociceptive processing mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Transcutaneous Spinal Direct Current Stimulation (tsDCS) in Patients With Chronic Pain: A Clinical and Neurophysiological Study. Guidetti, M., Ferrucci, R., Vergari, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cerebellar Transcranial Direct Current Stimulation (ctDCS) Ameliorates Phantom Limb Pain and Non-painful Phantom Limb Sensations. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in the management of phantom limb pain: a systematic review of randomized controlled trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Combined and Alone Transcranial Motor Cortex Stimulation and Mirror Therapy in Phantom Limb Pain: A Randomized Factorial Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation (tDCS) Targeting Left Dorsolateral Prefrontal Cortex Modulates Task-Induced Acute Pain in Healthy Volunteers. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Transcranial direct-current stimulation reduces nociceptive behaviour in an orofacial pain model. [2019]

8. Norway pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation for chronic pain]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation Combined With Patient-Controlled Intravenous Morphine Analgesia on Analgesic Use and Post-Thoracotomy Pain. A Prospective, Randomized, Double-Blind, Sham-Controlled, Proof-of-Concept Clinical Trial. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Transcutaneous Spinal Direct Current Stimulation (tsDCS) in Patients With Chronic Pain: A Clinical and Neurophysiological Study. [2021]