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The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

Primary Purpose

Tremor, Limb

Status
Completed
Phase
Not Applicable
Locations
Belgium
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 SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Above 18
  • Signed informed consents

Exclusion Criteria:

  • Pregnancy
  • History of Epilepsy
  • Family history of Epilepsy

Sites / Locations

  • KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Head stimulation

Arm stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in tremor-stimulation phase entrainment- Session 1
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Change in tremor-stimulation phase entrainment- Session 2
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Change in tremor-stimulation phase entrainment- Session 3
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal

Secondary Outcome Measures

Sensation 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.
Sensation threshold
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).

Full Information

First Posted
February 5, 2019
Last Updated
August 21, 2019
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04065022
Brief Title
The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
Official Title
The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
January 16, 2018 (Actual)
Study Completion Date
January 16, 2018 (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. 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.

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
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Head stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm stimulation
Arm Type
Experimental
Arm Description
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.
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
Change in tremor-stimulation phase entrainment- Session 1
Description
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Time Frame
During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Title
Change in tremor-stimulation phase entrainment- Session 2
Description
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Time Frame
During session two of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Title
Change in tremor-stimulation phase entrainment- Session 3
Description
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Time Frame
During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Secondary Outcome Measure Information:
Title
Sensation rating
Description
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.
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
Sensation threshold
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Above 18 Signed informed consents Exclusion Criteria: Pregnancy History of Epilepsy Family history of Epilepsy
Facility Information:
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

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