Tremor, LimbNCT04065022
The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
A study testing tACS at tremor frequency in people with Tremor, Limb, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tremor, Limb
- What is being tested?
- tACS at tremor frequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jun 2017to 16 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18
- Signed informed consents
Who cannot join
- Pregnancy
- History of Epilepsy
- Family history of Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- tACS at tremor frequency
- Medical subject headings
- Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS at tremor frequencyDevice
tACS applied between the stimulation electrodes at tremor frequency
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tACS at tremor frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tremor-stimulation phase entrainment- Session 1
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Measured: 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
Measured: 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
Measured: During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Secondary outcomes (2)
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.
Measured: 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
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).
Measured: Measured 3 minutes before the start of the stimulation sessions and lasts up to 2 minutes. Stimulation at each amplitude lasts for 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start20 Jun 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tremor, LimbStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myles Mc Laughlin, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065022
- Sponsor's protocol ID
- S57869-1
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
- ClinicalTrials.gov ID
- NCT04065022
- Acronym / sponsor ID
- S57869-1
- Conditions
- Tremor, Limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head stimulation | Experimental | Device: tACS at tremor frequencyEach 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 stimulation | Experimental | Device: tACS at tremor frequencyEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18
- Signed informed consents
Key exclusion criteria (3 listed)
- Pregnancy
- History of Epilepsy
- Family history of Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACS at tremor frequencytACS applied between the stimulation electrodes at tremor frequency | Device | Arm stimulation, Head stimulation |
Primary outcome
Change in tremor-stimulation phase entrainment- Session 1
Time frame: During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Change in tremor-stimulation phase entrainment- Session 2
Time frame: During session two of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Change in tremor-stimulation phase entrainment- Session 3
Time frame: During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
2 secondary outcomes
Sensation rating
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
Sensation threshold
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS at tremor frequency in people with Tremor, Limb, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tremor-stimulation phase entrainment- Session 1 (time frame: During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.