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Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor

Primary Purpose

Tremor, Limb

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tACS at tremor frequency
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tremor, Limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Above 18
  • signed informed written consent

Exclusion Criteria:

  • Pregnancy
  • History of Epilepsy
  • Family history of Epilepsy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Non-Focused stimulation

    Focused stimulation

    Arm Description

    Stimulation frequency is set similar to that of the tremor and the amplitude is set up to 2 mA peak amplitude (reduced if not uncomfortable). One 5*5 cm2 square patch electrodes are placed over the Motor cortex and the Prefrontal cortex respectively and a common return electrode of 10*10 cm2 over the ankle. Each subject follows three sessions of 12 min length each. During each session the tremor is measured while interleaving between Motor cortex stimulation, Prefrontal cortex stimulation and No stimulation. By the end of each session we get 4 min of Motor Cortex stimulation, 4 min of Prefrontal Cortex stimulation and 4 min of No stimulation.

    Stimulation frequency is set similar to that of the tremor and the amplitude is set up to 5 mA peak amplitude (with the help of local anesthetic cream and amplitude is reduced if not uncomfortable). A set of 4*1 gel-filled cup-electrodes is placed over each of motor cortex and the occipital cortex respectively. Each subject follows three sessions of 12 min length each. During each session the tremor is measured while interleaving between Motor cortex stimulation, Occipital cortex stimulation and No stimulation. By the end of each session we get 3 min of Motor Cortex stimulation, 3 min of occipital Cortex stimulation and 6 min of No stimulation.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Phosphene rating
    The subject is asked to rate the phosphene intensity during the stimulation using a visual analog scale from 0 to 10. Zero means no phosphene is perceived and the number starts to increase as the phosphene perception intensity increases to reach 10 if the subject observe only a white view
    Phosphene threshold
    Stimulation amplitude at which the subject starts to perceive phosphene. Stimulation starts with 0 mA amplitude and then increased gradually until phosphene is perceived (or reaching maximum amplitude).

    Full Information

    First Posted
    November 1, 2017
    Last Updated
    November 8, 2017
    Sponsor
    KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03337334
    Brief Title
    Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor
    Official Title
    Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    April 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    KU Leuven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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. While tACS applied over the motor cortex at the general applied amplitude (1 mA) and using patch electrodes has been shown to entrain physiological tremor in healthy volunteers, the aim of this study is to test the feasibility of using high-amplitude tACS and to assess the effect of different electrode montages and stimulation sites in entraining physiological tremor. First, 10 subjects (arm 1) will be stimulated with 2 mA current amplitude applied between saline soaked patch square electrodes and comparison will be done between motor cortex stimulation and peripheral cortex stimulation. Then, 10 subjects (arm 2) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes and 5 mA amplitude and comparison will be made between motor cortex and occipital cortex stimulation. Three outcome measurements will be measured during the experiments which are: tremor entrainment, phosphene intensity and phosphene threshold.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tremor, Limb

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-Focused stimulation
    Arm Type
    Other
    Arm Description
    Stimulation frequency is set similar to that of the tremor and the amplitude is set up to 2 mA peak amplitude (reduced if not uncomfortable). One 5*5 cm2 square patch electrodes are placed over the Motor cortex and the Prefrontal cortex respectively and a common return electrode of 10*10 cm2 over the ankle. Each subject follows three sessions of 12 min length each. During each session the tremor is measured while interleaving between Motor cortex stimulation, Prefrontal cortex stimulation and No stimulation. By the end of each session we get 4 min of Motor Cortex stimulation, 4 min of Prefrontal Cortex stimulation and 4 min of No stimulation.
    Arm Title
    Focused stimulation
    Arm Type
    Other
    Arm Description
    Stimulation frequency is set similar to that of the tremor and the amplitude is set up to 5 mA peak amplitude (with the help of local anesthetic cream and amplitude is reduced if not uncomfortable). A set of 4*1 gel-filled cup-electrodes is placed over each of motor cortex and the occipital cortex respectively. Each subject follows three sessions of 12 min length each. During each session the tremor is measured while interleaving between Motor cortex stimulation, Occipital cortex stimulation and No stimulation. By the end of each session we get 3 min of Motor Cortex stimulation, 3 min of occipital Cortex stimulation and 6 min of No stimulation.
    Intervention Type
    Device
    Intervention Name(s)
    tACS at tremor frequency
    Intervention Description
    tACS applied between the stimulation electrodes at tremor frequency
    Primary Outcome Measure Information:
    Title
    Tremor-stimulation phase entrainment
    Description
    phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
    Time Frame
    During the 36 minutes of all sessions (3 sessions each of is 12 minutes)
    Secondary Outcome Measure Information:
    Title
    Phosphene rating
    Description
    The subject is asked to rate the phosphene intensity during the stimulation using a visual analog scale from 0 to 10. Zero means no phosphene is perceived and the number starts to increase as the phosphene perception intensity increases to reach 10 if the subject observe only a white view
    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
    Title
    Phosphene threshold
    Description
    Stimulation amplitude at which the subject starts to perceive phosphene. Stimulation starts with 0 mA amplitude and then increased gradually until phosphene is perceived (or reaching maximum amplitude).
    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 sec.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Above 18 signed informed written consent Exclusion Criteria: Pregnancy History of Epilepsy Family history of Epilepsy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor

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