Remote tDCS + Somatosensory Training for Phantom Limb Pain

(PLP-EVEREST Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Unstable medical, Psychiatric, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators have designed a pragmatic trial of home-based transcranial direct current stimulation (tDCS) for phantom limb pain (PLP), the PLP-EVEREST trial (PLP-EffectiVEness pRagmatic Stimulation Trial) to test a portable device that would reach underrepresented populations and would validate this therapy in a more pragmatic setting. Subjects will be randomized to home-based tDCS of the primary motor cortex (M1) with somatosensory training or usual care only (including their current pharmacological treatments, physical therapy, and occupational therapy). The investigators will therefore test the effectiveness of home-based tDCS and somatosensory training in a real-world, home-based setting. The Investigator will compare patients randomized to this combined strategy vs. usual care alone (subjects from this group will be offered combined treatment at the end of the trial). The investigators hypothesize that the combined strategy will be associated with a significantly larger Cohen's d effect size (at least 1) compared to the control group.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial allows participants to continue their usual care, including current medications, physical therapy, and occupational therapy.

What data supports the effectiveness of the treatment Remote tDCS + Somatosensory Training for Phantom Limb Pain?

Research shows that transcranial direct current stimulation (tDCS) over the motor cortex can reduce phantom limb pain (PLP) by modulating brain activity, with studies indicating both immediate and sustained pain relief. Additionally, combining tDCS with other therapies like motor imagery or mirror therapy has shown potential benefits in managing PLP, suggesting that the combined approach of Remote tDCS and Somatosensory Training could be effective. ^{1 2 3 4 5}

Is remote tDCS with somatosensory training safe for humans?

Research on transcranial direct current stimulation (tDCS), including home-based and anodal tDCS, suggests it is generally safe for humans. Studies have shown it can be used without significant side effects for conditions like phantom limb pain, although individual responses may vary. ^{1 3 4 5 6}

How does the treatment of Remote tDCS + Somatosensory Training for Phantom Limb Pain differ from other treatments?

This treatment is unique because it combines home-based transcranial direct current stimulation (tDCS) with somatosensory training, allowing patients to receive therapy remotely. The use of anodal tDCS on the primary motor cortex (M1) is designed to increase brain excitability and reduce phantom limb pain by modulating neuroplasticity, which is different from other treatments that may not target these specific brain areas or use this combination of techniques. ^{1 3 4 5 7}

Research Team

Eligibility Criteria

This trial is for adults over 18 with limb amputations who regularly experience phantom limb pain (PLP) at least once a week, and have chronic pain rated at least 4 on the numeric rating scale. It's not suitable for those with significant medical or psychiatric disorders, recent substance abuse, uncompensated psychiatric conditions, major neurological history or neurosurgery affecting tDCS distribution, or implanted brain devices.

Inclusion Criteria

I am older than 18 years.

I experience chronic pain with an average intensity of at least 4 out of 10.

I have had a limb amputated.

Exclusion Criteria

You have a mental health condition that is not being managed or treated.

I do not have any serious or unstable health or mental conditions.

I've had brain surgery that could affect electrical therapy on my head.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 daily sessions of active anodal M1 home-based tDCS combined with somatosensory training or usual care

4 weeks

20 visits (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

3 visits (in-person)

Treatment Details

Interventions

• M1 anodal home-based tDCS (Transcranial Direct Current Stimulation Device)
• Somatosensory Training (Behavioral Intervention)

Trial Overview The study tests home-based transcranial direct current stimulation (tDCS) of the primary motor cortex combined with somatosensory training against usual care including medication and physical therapy. The goal is to see if this strategy can significantly reduce PLP in a real-world setting compared to usual care alone.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Usual care includes pharmacological treatments, physical therapy, occupational therapy and/or behavioral therapy that the subject is receiving.

Group II: M1 anodal home-based tDCS and somatosensory training Experimental Treatment 2 Interventions

Investigators will use the Soterix Medical 1X1 tDCS mini-CT stimulator device (© Soterix Medical Inc.) an home-based tDCS device used in several clinical trials with no adverse events. It sends a low-level current from the positive electrode, anode, to the negative electrode, cathode. During tDCS, low amplitude direct currents are applied via scalp electrodes and penetrate the skull to enter the brain. HB-TDCS will be combined with somatosensory training that will be performed during the self-administration of tDCS, including 20 sessions over 4 weeks.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Spaulding Hospital Cambridge Cambridge, MA

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Patients Recruited

11,200+

Findings from Research

This pilot study will evaluate the feasibility and preliminary efficacy of a home-based treatment combining anodal tDCS and motor imagery for managing phantom limb pain in 10 participants over 20 sessions.

The study aims to identify predictors of treatment response, which could help tailor future therapies for phantom limb pain and improve access to effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based transcranial direct current stimulation (tDCS) and motor imagery for phantom limb pain using statistical learning to predict treatment response: an open-label study protocol. Pacheco-Barrios, K., Cardenas-Rojas, A., de Melo, PS., et al.[2022]

A 5-day treatment with active transcranial direct current stimulation (tDCS) over the motor cortex significantly reduced phantom limb pain (PLP) in 8 amputees, providing sustained relief for up to a week after treatment.

Patients experienced immediate pain relief and improved movement ability of their phantom limb during active tDCS sessions, while sham tDCS showed inconsistent effects, highlighting the potential of tDCS as a promising non-pharmacological treatment for chronic neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and Sustained Effects of 5-Day Transcranial Direct Current Stimulation of the Motor Cortex in Phantom Limb Pain. Bolognini, N., Spandri, V., Ferraro, F., et al.[2022]

Transcranial direct current stimulation (tDCS) can effectively reduce phantom limb pain (PLP) in amputees, with anodal stimulation of the primary motor cortex leading to a short-lasting decrease in pain sensations.

The study also found that nonpainful phantom sensations can be reduced by cathodal tDCS of the posterior parietal cortex, indicating that painful and nonpainful phantom sensations are distinct and can be targeted differently with tDCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor and parietal cortex stimulation for phantom limb pain and sensations. Bolognini, N., Olgiati, E., Maravita, A., et al.[2022]

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]

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]

References

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

Home-based transcranial direct current stimulation (tDCS) and motor imagery for phantom limb pain using statistical learning to predict treatment response: an open-label study protocol. [2022]

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

Immediate and Sustained Effects of 5-Day Transcranial Direct Current Stimulation of the Motor Cortex in Phantom Limb Pain. [2022]

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

Motor and parietal cortex stimulation for phantom limb pain and sensations. [2022]

4. 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]

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

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

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

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

7. 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]