Long-term Effects of Transcranial Direct Current Stimulation (tDCS) on Patients With Phantom Limb Pain (PLP)

Long-Term Treatment of Patients Experiencing Phantom Limb Pain With Transcranial Direct Current Stimulation (tDCS)

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02051959

Enrollment

Registered

2014-01-31

Start date

2015-05-31

Completion date

2017-12-31

Last updated

2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phantom Limb Pain

Keywords

Phantom Limb Pain, Transcranial Direct Current Stimulation, Amputation, Diabetes Mellitus

Brief summary

* Phantom limb pain (PLP) refers to pain in a limb that has been amputated or deafferented. Phantom limb pain might be related to brain cortical plastic changes. * The purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain. This is a Crossover sham control.

Interventions

DEVICEAnodal stimulation of M1 + sham

8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.

DEVICESham + Anodal stimulation of M1

8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).

DEVICECathodal stimulation of M1 + sham

8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.

DEVICESham + Cathodal stimulation of M1

8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Age 18 to 80 * Limb amputation from at least 6 months before study enrollment * Presence of PLP at least 2 times a week and present 4 weeks prior to onset of study * Written informed consent

Exclusion criteria

* Coexistence of major neurological or psychiatric diseases * Being actively enrolled in a separate study targeting pain relief * Post traumatic stress disorder (PTSD) diagnosed patients * Any contraindication to noninvasive brain stimulation such as past brain surgery, brain implants, cochlear implant, epilepsy or any past seizure * Pregnant women * Within the traumatic amputees group - subjects diagnosed with diabetes

Design outcomes

Primary

Measure	Time frame	Description
Reduced phantom limb pain	5 months after last stimulation session	Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation

Secondary

Measure	Time frame	Description
Adverse effects of treatment	Up to 5 weeks	Severity of any adverse effects related to the transcranial direct current stimulation treatment will be checked after each stimulation session
Effects of treatment on the electrical activity of the brain	Up to 5 weeks	Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026