The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

NCT ID: NCT04065022

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2018-01-16

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.

Conditions

Tremor, Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

tACS at tremor frequency

Intervention Type: DEVICE

tACS applied between the stimulation electrodes at tremor frequency

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.

Group Type: EXPERIMENTAL

tACS at tremor frequency

Intervention Type: DEVICE

tACS applied between the stimulation electrodes at tremor frequency

Interventions

tACS at tremor frequency

tACS applied between the stimulation electrodes at tremor frequency

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Above 18
• Signed informed consents

Exclusion Criteria

• Pregnancy
• History of Epilepsy
• Family history of Epilepsy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Myles Mc Laughlin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S57869-1

Identifier Type: -

Identifier Source: org_study_id