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CompletedNCT04432363Updated Oct 30, 2020

Effects of tDCS in M1 and DLPFC on Pain Processing in Healthy Volunteers

An interventional study of Transcranial direct current stimulation in Pain Processing in Healthy Volunteers, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-30.

Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing.

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Conditions studied

  • Pain Processing in Healthy Volunteers
03

In context

Lead sponsor

Universidad Rey Juan Carlos is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 18 and 40 years
  • Comprehension of the study tasks

Exclusion criteria

Exclusion Criteria:

  • Presence of pain in the previous 6 months
  • Altered sensitivity in the tested regions
  • Intolerance to electrotherapy
  • Presence of pacemakers or any other implanted device
  • Ulcers or scars in the skin at the location of the electrodes
  • Treatment with direct current stimulation within one week
  • Pregnancy
  • Frequent headaches
  • Epilepsy
  • History of neuromuscular disease
  • Previous clinical history of cervical surgery
  • Injuries or surgery affecting the upper limb
  • diabetes mellitus
  • Cardiovascular diseases
  • Oncological diseases
  • Consumption of analgesic drugs 7 days before the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    M1 stimulation

    A 20 minutes 1mA direct current stimulation over left M1.

    Device: Transcranial direct current stimulation

  • Active comparator
    M1+DLPFC stimulation

    A 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC.

    Device: Transcranial direct current stimulation

  • Sham comparator
    Sham stimulation

    A 20 minutes sham stimulation where the device only is working first 30s and last 30s of the intervention and have a 10 seconds fade out in intensity at each ramp.

    Device: Transcranial direct current stimulation

Interventions

  • DeviceTranscranial direct current stimulation

    Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).

06

What researchers measure

Primary outcomes

  1. Conditioned Pain Modulation

    Pain pressure threshold change after a painful ischemic stimulus

    Time frame: Pre-intervention and immediately after treatment

  2. Pain pressure algometer temporal summation

    Change in pain perceived between the first and tenth painful pressure stimulus

    Time frame: Pre-intervention and immediately after treatment

Secondary outcomes

  1. Pain pressure threshold

    Measurement of pressure applied until the perception of pain

    Time frame: Pre-intervention and immediately after treatment

  2. Pain pressure tolerance

    Measurement of maximal painful pressure tolerate using a pressure algometer

    Time frame: Pre-intervention and immediately after treatment

  3. Neural mechanosensitivity

    Measurement of range of motion achieved until the perception of tension

    Time frame: Pre-intervention and immediately after treatment

  4. Cold hyperalgesia with a cold pack

    Pain rated in a visual analogue scale after 10 seconds of a cold stimulus

    Time frame: Pre-intervention and immediately after treatment

  5. Isometric grip strength

    Maximal pressure achieved in a isometric gripping task

    Time frame: Pre-intervention and immediately after treatment

07

Study locations

1 site
  • Universidad Rey Juan Carlos
    Alcorcon, Madrid 28922, Spain
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04432363
Lead sponsor
Universidad Rey Juan Carlos
Responsible party
Josue Fernandez Carnero (Associate Professor, Universidad Rey Juan Carlos) — Principal investigator
First posted
Jun 16, 2020
Start date
Jun 6, 2020
Primary completion
Jul 25, 2020
Completion
Jul 25, 2020
Last update
Oct 30, 2020

Study contacts

Josue Fernandez Carnero, PhD
study director · Universidad Rey Juan Carlos

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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