Tremor, LimbNCT03337334
Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor
A study testing tACS at tremor frequency in people with Tremor, Limb, run by KU Leuven.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 23 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Apr 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18
- signed informed written consent
Who cannot join
- Pregnancy
- History of Epilepsy
- Family history of Epilepsy
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. 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.
- 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 |
|---|---|---|
| Non-Focused stimulation | Other | 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. Receives: Device: tACS at tremor frequency |
| Focused stimulation | Other | 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. Receives: Device: tACS at tremor frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor-stimulation phase entrainment
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
Measured: During the 36 minutes of all sessions (3 sessions each of is 12 minutes)
Secondary outcomes (2)
Phosphene rating
The subject is asked to rate the phosphene intensity during the stimulation using a visual analog scale from 0 to 10. Zero means no phosphene is perceived and the number starts to increase as the phosphene perception intensity increases to reach 10 if the subject observe only a white view
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
Phosphene threshold
Stimulation amplitude at which the subject starts to perceive phosphene. Stimulation starts with 0 mA amplitude and then increased gradually until phosphene 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 sec.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study startJun 2016
- Primary completionApr 2017
- Study completionApr 2017
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Khatoun, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337334
- Sponsor's protocol ID
- S57869
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 9 Nov 2017
- 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 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Amplitude and Focused tACS on Entraining Physiological Tremor
- ClinicalTrials.gov ID
- NCT03337334
- Acronym / sponsor ID
- S57869
- Conditions
- Tremor, Limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 9 Nov 2017 (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. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Focused stimulation | Other | Device: tACS at tremor frequencyStimulation 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. |
| Focused stimulation | Other | Device: tACS at tremor frequencyStimulation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Above 18
- signed informed written consent
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 | Focused stimulation, Non-Focused stimulation |
Primary outcome
Tremor-stimulation phase entrainment
Time frame: During the 36 minutes of all sessions (3 sessions each of is 12 minutes)
phase locking value was calculated between the tremor signal measured using accelerometer and the stimulation signal
2 secondary outcomes
Phosphene 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
Phosphene 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 sec.
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 9 Nov 2017.
- 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.
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.
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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Tremor-stimulation phase entrainment (time frame: During the 36 minutes of all sessions (3 sessions each of is 12 minutes)). 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 9 Nov 2017.