Study type: Therapeutical study (experimental study)

Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. med. app.

Published in: Biol Psychiatry 2010; 68 (2): 163-169

Aim of study (acc. to author)

To evaluate the antidepressant effect of a new treatment principle using low-intensity transcranially applied pulsed electromagnetic fields (T-PEMF) in combination with antidepressants in patients with treatment-resistant depression.

Background/further details

The psychopharmacological treatment (antidepressants, mood stabilizers, antipsychotics, tranquilizers, and hypnotics) was unchanged during the previous four weeks (before treatment) and was maintained on the same dosage throughout the study. In total, 50 patients were included (from June 2006 to February 2009; treatment group n=25, sham exposure group n=25).
See here for additional information.

Endpoint

Exposure

Exposure Parameters
Exposure 1: 55 Hz
Modulation type: pulsed
Exposure duration: 5 days/week for 5 weeks

Exposure 1

Main characteristics
Frequency 55 Hz
Type
Waveform
  • rectangular
Exposure duration 5 days/week for 5 weeks
Modulation
Modulation type pulsed
Pulse width 3 ms
Repetition frequency 55 Hz
Pulse type biphasic
Additional info

pulses with a 12 ms pause between them

Exposure setup
Exposure source
Setup plastic treatment helmet with 7 coils: two in the anterior and posterior temporal region on both sides, one in the upper parietal region on both sides and one in the center of the lower occipital region
Sham exposure A sham exposure was conducted.
Parameters
Measurand Value Type Method Mass Remarks
electric field strength 2.2 mV/cm - measured - at a distance of 0.5 cm from the coil
electric field strength 30 µV/cm - measured - at a distance of 10 cm from the coil
magnetic flux density 1.9 mT maximum calculated - -

Exposed system:

Methods Endpoint/measurement parameters/methodology

Investigated system:
Investigated organ system:
Time of investigation:
  • before exposure
  • during exposure

Main outcome of study (acc. to author)

Patients exposed to active transcranially applied pulsed electromagnetic fields showed a clinically and statistically significant better outcome than patients treated with sham exposure condition, with an onset of action within the first weeks of therapy. Treatment-emergent side effects were few and mild.

Study character:

Study funded by

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