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The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065022
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Myles Mc Laughlin, KU Leuven

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tremor, Limb Device: tACS at tremor frequency Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : January 16, 2018


Arm Intervention/treatment
Experimental: Head stimulation
Each subject will be stimulated at two different days. One day with the presence of topical anesthetic cream on the scalp above the MC and in the other day with absence of the anesthetic cream. Stimulation frequency is set similar to that of the tremor. Three stimulation amplitudes will be tested (0 mA, 0.5 mA and 2.5 mA -reduced if not uncomfortable). A set of 4*1 gel-filled cup-electrodes is placed over each of motor cortex. Each subject follows three sessions of 12 min length each day. During each session the tremor is measured while interleaving between low amplitude stimulation, high amplitude stimulation and No stimulation. By the end of each session we get 3 min of Low amplitude stimulation, 3 min of high amplitude stimulation and 6 min of No stimulation.
Device: tACS at tremor frequency
tACS applied between the stimulation electrodes at tremor frequency

Experimental: Arm stimulation
Each subject will be stimulated on only one day. Stimulation frequency is set similar to that of the tremor. Three stimulation amplitudes will be tested (0 mA, 0.5 mA and 2.5 mA -reduced if not uncomfortable). A set of 2*1 gel-filled cup-electrodes is placed over the contralateral arm. Each subject follows three sessions of 12 min length. During each session the tremor is measured while interleaving between low amplitude stimulation, high amplitude stimulation and No stimulation. By the end of each session we get 3 min of Low amplitude stimulation, 3 min of high amplitude stimulation and 6 min of No stimulation.
Device: tACS at tremor frequency
tACS applied between the stimulation electrodes at tremor frequency




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above 18
  • Signed informed consents

Exclusion Criteria:

  • Pregnancy
  • History of Epilepsy
  • Family history of Epilepsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065022


Locations
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Belgium
KU Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
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Responsible Party: Myles Mc Laughlin, Principal Investigator, KU Leuven
ClinicalTrials.gov Identifier: NCT04065022    
Other Study ID Numbers: S57869-1
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases