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Transcranial Direct Current Stimulation Device

Remote tDCS + Somatosensory Training for Phantom Limb Pain (PLP-EVEREST Trial)

N/A

Recruiting

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age - older than 18 years

Current chronic pain as defined by an average pain of at least 4 on the numeric rating scale (NRS, 0: no pain, 10: worst imaginable pain)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to visit 22 (at 4 weeks)

Awards & highlights

PLP-EVEREST Trial Summary

This trialwill test a portable device to treat phantom limb pain with home-based tDCS combined with somatosensory training, to be compared to usual care alone. Results will measure the effectiveness of the combined strategy vs. usual care.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of tDCS may include mild tingling, itching or discomfort at the electrode site during application. Less common side effects could be headache, fatigue, nausea or insomnia. Serious risks are rare but might involve skin burns or seizures.

PLP-EVEREST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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

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I have had a limb amputated.

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I experience phantom limb pain at least once a week.

PLP-EVEREST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to visit 22 (at 4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to visit 22 (at 4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to visit 22 (at 4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual Analogue Scale (VAS) for Phantom Limb Pain

PLP-EVEREST Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment1 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 trainingExperimental Treatment2 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spaulding Rehabilitation HospitalLead Sponsor

135 Previous Clinical Trials

10,765 Total Patients Enrolled

Media Library

M1 anodal home-based tDCS (Transcranial Direct Current Stimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05188183 — N/A

Phantom Limb Pain Research Study Groups: Usual Care, M1 anodal home-based tDCS and somatosensory training

Phantom Limb Pain Clinical Trial 2023: M1 anodal home-based tDCS Highlights & Side Effects. Trial Name: NCT05188183 — N/A

M1 anodal home-based tDCS (Transcranial Direct Current Stimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05188183 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this clinical trial currently accommodating?

"Affirmative. Information on the clinicaltrials.gov website states that this investigation, which was first published on October 1st 2022, is in need of participants. Approximately 290 patients must be registered from one medical facility."

Answered by AI

Is this research initiative currently seeking participants?

"This trial, which was made available to the public on October 1st 2022, is actively enrolling patients. Clinicaltrials.gov recently updated this study's information on January 13th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response

Felipe Fregni, MD, PhD, MPH 2022. "Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05188183.