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

NARecruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

June 30, 2027

Study Completion Date

July 31, 2027

Conditions
Phantom Limb Pain
Interventions
DEVICE

M1 anodal home-based tDCS

During tDCS, low amplitude direct currents are applied via scalp electrodes and penetrate the skull to enter the brain. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2) and delivered by a specially developed, battery-driven, constant current stimulator with a maximum output of 10 mA.

BEHAVIORAL

Somatosensory Training

The somatosensory training will be performed during the self-administration of tDCS, including 20 sessions over 4 weeks. Sessions will start with relaxation exercises using a body scan technique, whereby subjects in a relaxed state will be instructed to sequentially interchange their mind to different regions of the body while perceiving it and establishing contact with the body part. Subjects will be asked to concentrate on any feeling (kinetic, kinesthetic or exteroceptive) related to each body part. Phantom exercises will involve the use of imagined movements of the phantom limb. Therefore, patients will be asked to perform general exercises with their phantom limb. Exercises will include hip, knee, ankle, and toe movements.

OTHER

Usual Care

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

Trial Locations (1)

02138

RECRUITING

Spaulding Hospital Cambridge, Cambridge

All Listed Sponsors
lead

Spaulding Rehabilitation Hospital

OTHER