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Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor

NCT ID: NCT03337334

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tremor, Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non-Focused stimulation

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.

Group Type OTHER

tACS at tremor frequency

Intervention Type DEVICE

tACS applied between the stimulation electrodes at tremor frequency

Focused 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.

Group Type OTHER

tACS at tremor frequency

Intervention Type DEVICE

tACS applied between the stimulation electrodes at tremor frequency

Interventions

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tACS at tremor frequency

tACS applied between the stimulation electrodes at tremor frequency

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Above 18
* signed informed written consent

Exclusion Criteria

* Pregnancy
* History of Epilepsy
* Family history of Epilepsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Khatoun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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S57869

Identifier Type: -

Identifier Source: org_study_id