Home-based treatment for phantom limb pain using brain stimulation and sensory training

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.