The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS

NCT04065022 | Completed

• 1 other identifier: S57869-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in tremor-stimulation phase entrainment- Session 1

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

  During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)

• Change in tremor-stimulation phase entrainment- Session 2

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

  During session two of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)

• Change in tremor-stimulation phase entrainment- Session 3

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

  During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)

Secondary Outcomes (2)

• Sensation rating

  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

• Sensation threshold

  Measured 3 minutes before the start of the stimulation sessions and lasts up to 2 minutes. Stimulation at each amplitude lasts for 10 seconds

Study Arms (2)

Head stimulation

EXPERIMENTAL

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

Arm stimulation

EXPERIMENTAL

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

Interventions

tACS at tremor frequency DEVICE

tACS applied between the stimulation electrodes at tremor frequency

Arm stimulation; Head stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18
• Signed informed consents

You may not qualify if:

• Pregnancy
• History of Epilepsy
• Family history of Epilepsy

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: August 22, 2019
• Study Start: June 20, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

BE (1)