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Completed

NCT Number: NCT04065022

The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. This has been shown to have effects on the motor system, cognition and behavior. The exact mechanism by which tACS causes such effects is not fully understood. Some studies suggests a contribution from the stimulated peripheral nerves present in the scalp rather than direct brain effects. To test this hypothesis two arms will be done. First, 12 subjects (arm 1) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes over the motor cortex and the effects will be compared between anesthetized and non-anesthetized scalp. The effects of anesthetizing the scalp will be tested on three different stimulation amplitudes off (0 mA), low (0.5 mA) and high (2.5 mA). Then, 10 subjects (arm 2) will be stimulated over the contralateral arm to exclude any direct brain stimulation effects and to test if peripheral nerve stimulation can entrain the tremor. Three outcome measurements will be measured during the experiments which are: tremor entrainment, sensation intensity and sensation threshold.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Above 18
  • Signed informed consents

Exclusion criteria

  • Pregnancy
  • History of Epilepsy
  • Family history of Epilepsy

Treatment and study plan

tACS at tremor frequency

Device

tACS applied between the stimulation electrodes at tremor frequency

Primary outcomes

  1. Change in tremor-stimulation phase entrainment- Session 1

    Time frame: During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)

    phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal

  2. Change in tremor-stimulation phase entrainment- Session 2

    Time frame: During session two of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)

    phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal

  3. Change in tremor-stimulation phase entrainment- Session 3

    Time frame: During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)

    phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal

Secondary outcomes

  1. Sensation rating

    Time frame: Measured up to 5 minutes before the start of the stimulation sessions and lasts for 10 seconds of stimulation after which the subject gives the rating

    The subject is asked to rate the sensation intensity during the stimulation at each stimulation amplitude using a visual analog scale from 0 to 10. Zero means the subject doesn't feel the stimulation and the number starts to increase as the sensation perception intensity increases to reach 10 if the subject feels it painful.

  2. Sensation threshold

    Time frame: Measured 3 minutes before the start of the stimulation sessions and lasts up to 2 minutes. Stimulation at each amplitude lasts for 10 seconds

    Stimulation amplitude at which the subject starts to feel the stimulation. Stimulation starts with 0 mA amplitude and then increased gradually until stimulation is perceived (or reaching maximum amplitude).

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2019
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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