Essential TremorELECTRENCT01579435
Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation
A study testing transcranial direct current stimulation in people with Essential Tremor, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Apr 2013
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years and < 50 years
- Important essential tremor (bilateral postural and/or action tremor since more than one year)
- Normal physical and neurological examination, except for essential tremor
- Insufficient efficiency of usual essential tremor's treatment
- No treatment altering the cortical excitability
- Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential
Who cannot join
- Cervical tremor
- Current neurological or psychiatric illness other than essential tremor
- Individual who is on medication which is known to lower seizure threshold
- Previous history of seizure(s), malaise or current active epilepsy
- Contraindication for MRI or TMS study
- Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
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- Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent
- Simultaneous participation in another clinical trial
- Patients who are not enrolled at social security
Trial locations and contacts
1 site in 1 country.
France1 site
Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière
Paris, 75651
About this study
Official title: Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.
- Conditions
- Essential Tremor
- Being tested
- transcranial direct current stimulation
- Keywords
- essential tremor, primary motor cortex, cerebellum, transcranial direct current stimulation, electrophysiology
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic tDCS | Experimental | 6 patients with essential tremor Receives: Device: transcranial direct current stimulation |
| Physiopathological tDCS | Experimental | 6 patients with essential tremor Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS
Measured: 10 minutes after the end of tDCS
Secondary outcomes (3)
Change from baseline in tremor amplitude on electromyographic recordings
Measured: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
Change from baseline in tremor amplitude on digitized tablet
Measured: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
Change from baseline in tremor amplitude on accelerometric recording
Measured: During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emmanuel Flamand-Roze, MD, Principal investigator, Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579435
- Sponsor's protocol ID
- C11-37
- Other IDs
- 2011-A01453-38
- Acronym
- ELECTRE
- Status last verified
- Apr 2013
- First submitted
- 5 Apr 2012
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.
- ClinicalTrials.gov ID
- NCT01579435
- Acronym / sponsor ID
- ELECTRE / C11-37
- Conditions
- Essential Tremor
- Keywords
- essential tremor, primary motor cortex, cerebellum, transcranial direct current stimulation, electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Apr 2012 (estimated)
- 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.
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic tDCS | Experimental | Device: transcranial direct current stimulation6 patients with essential tremor |
| Physiopathological tDCS | Experimental | Device: transcranial direct current stimulation6 patients with essential tremor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and < 50 years
- Important essential tremor (bilateral postural and/or action tremor since more than one year)
- Normal physical and neurological examination, except for essential tremor
- Insufficient efficiency of usual essential tremor's treatment
- No treatment altering the cortical excitability
Key exclusion criteria (9 listed)
- Cervical tremor
- Current neurological or psychiatric illness other than essential tremor
- Individual who is on medication which is known to lower seizure threshold
- Previous history of seizure(s), malaise or current active epilepsy
- Contraindication for MRI or TMS study
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 |
|---|---|---|
| transcranial direct current stimulationActive stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum; | Device | Physiopathological tDCS, Therapeutic tDCS |
Primary outcome
Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS
Time frame: 10 minutes after the end of tDCS
3 secondary outcomes
Change from baseline in tremor amplitude on electromyographic recordings
Time frame: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
Change from baseline in tremor amplitude on digitized tablet
Time frame: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
Change from baseline in tremor amplitude on accelerometric recording
Time frame: During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS
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 11 Apr 2013.
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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.
Emmanuel Flamand-Roze, MD principal investigator
Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Essential Tremor, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 6 inclusion and 9 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 11 Apr 2013. 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 France. 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 from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS (time frame: 10 minutes after the end of tDCS). 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 11 Apr 2013.