Home-based treatment for phantom limb pain using brain stimulation and sensory training
Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
This study is testing whether a new home-based treatment combining brain stimulation and sensory training can help people with phantom limb pain feel better compared to their usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT05188183 on ClinicalTrials.gov |
What this trial studies
This trial tests the effectiveness of a home-based transcranial direct current stimulation (tDCS) device combined with somatosensory training for individuals suffering from phantom limb pain (PLP). Participants will be randomized to receive either the combined treatment or usual care, which includes their current medications and therapies. The study aims to validate this approach in a real-world setting, focusing on underrepresented populations. Over 12 weeks, participants will undergo 20 sessions of treatment to assess pain relief and overall effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a history of limb amputation and chronic phantom limb pain occurring at least once a week.
Not a fit: Patients with unstable medical or psychiatric disorders, recent substance abuse, or contraindications to tDCS will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce phantom limb pain and improve quality of life for patients.
How similar studies have performed: Other studies have shown promise with tDCS for pain management, but this specific combination approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age - older than 18 years 2. Limb amputation 3. Patients who experience PLP regularly (at least once a week) 4. Pain not attributable to other causes, such as peripheral inflammation 5. 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) Exclusion Criteria: 1. Any clinically significant or unstable medical or psychiatric disorder 2. History of substance abuse in the past 6 months (according to the DSM-V criteria for substance use disorder with six or more symptoms) 3. Uncompensated psychiatric disorder 4. Previous significant neurological history with current significant neurological deficits 5. Previous neurosurgical procedure with craniectomy that would affect current distribution of tDCS 6. Contraindications to tDCS (implanted brain medical devices)
Where this trial is running
Cambridge, Massachusetts
- Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Felipe Fregni, MD, PhD, MPH, MMSc
- Email: ffregni@partners.org
- Phone: 617-952-6158
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.