Preventing Chronification of Phantom Limb Pain Through Mirror Therapy in Conjunction With tDCS

NARecruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

March 25, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

March 31, 2029

Conditions
Phantom Limb Pain After Amputation
Interventions
DEVICE

Trans Direct-Cranial Stimulation (tDCS)

The tDCS electrodes will be inserted into 5×7 cm (35 cm2) sponges soaked with saline (0.9 M) and placed as follows: anode over the M1 contralateral to the amputated limb (adjusted based on lower/upper amputation), and cathode over the forehead, contralateral to the anode (ipsilateral to amputated limb). Total stimulation duration will be 20 min, with a rise and decline time of 30 sec and stimulus intensity of 1.5 mA for the real tDCS real. The intensity of 1.5 mA is in the midrange of recommended intensities (1-2 mA) and supports successful blinding. The sham tDCS will be identical to the real tDCS, except no current will be applied. However, as recommended, during the first and last 30 sec, the current will be ramped up to 1.5 mA and immediately back to 0 to induce scalp sensations similar to those in real tDCS, further supporting blinding. The Mini-CT tDCS Stimulator device has been developed for home use and allows double-blind administration.

BEHAVIORAL

Mirror therapy

Participants will be seated with a portable mirror between their limbs so that the unaffected limb is reflected in the mirror. The participants will focus their attention on the reflection in the mirror and perform the following movements: plantarflexion and dorsiflexion and inversion and eversion of the foot, flexion and extension of the wrist and ulnar and radial deviation, for lower and upper limp amputates, respectively. The participants will continue performing the 2 sets of movements for 20 minutes (with short intermissions if needed)

Trial Locations (3)

Ahuza 278

RECRUITING

Loewenstein Hospital, Raanana

Unknown

RECRUITING

Reut Medical Center, Tel Aviv

NOT_YET_RECRUITING

Sheba Medical Center, Tel Aviv

All Listed Sponsors
collaborator

Loewenstein Hospital

OTHER

collaborator

Reuth Rehabilitation Hospital

OTHER

collaborator

Sheba Medical Center

OTHER_GOV

lead

University of Haifa

OTHER