Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor

Primary Orthostatic Tremor Clinical Trial

— STOP  

Official title:

Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978924
• Other study ID #: C16-26
• Secondary ID: 2016-A01202-49
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: November 28, 2017

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the effect of cathodal tsDCS vs sham tsDCS in primary orthostatic tremor. The investigators hypothesize that cathodal tsDCS but not sham tsDCS would be able to restore both motor and sensory pathways of the spinal cord leading to functional improvements.

Description:

Regain of function and improvement of motor skills is a major challenge in motor disorders in which spinal cord functions play a key role. The growing development of non-invasive brain stimulations in the past decade led to significant progress in the understanding of neuronal abnormalities in patients with movement disorders that opens up new vistas for experimental treatments. However, these treatments are currently limited due to their high cost and lack of possibility to use in outpatients. Recently, trans-spinal direct current stimulation (tsDCS) has emerged as a novel tool to modulate non-invasively spinal cord excitability. This may be an excellent alternative to epidural stimulation, the sole technique available up to now to alter spinal functions in an invasive fashion. The overall goal of this study is to assess the potential of tsDCS to restore spinal cord functions in patients with primary orthostatic tremor (POT), a disorder with little or no current therapeutic resources and high disability for patients.

Using a crossover, randomized, double-blinded approach, cathodal (2mA, 20 min) or sham tsDCS (with the active electrodes over the thoracic level and the reference electrode on the right shoulder) will be delivered to 15 patients with POT. The maximal time in upright position determined by a force platform, the cortical excitability assessed by transcranial magnetic stimulation (input / output curve of the tibialis anterior muscle and short-latency afferent inhibition) and EMG activities of lower extremity muscles will be measured before (PRE), immediately and 30 minutes after current offset (POST0 and POST30 respectively). Cathodal and sham tsDCS will be delivered in two different sessions with a washout period of at least 7 days. The investigators anticipate that cathodal tsDCS but not sham tsDCS will be able to modulate both sensory and motor functions in POT and will, in turn, lead to functional improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 28, 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with POT diagnosed since at least 1 year

• Normal neurological examination with the exception of POT

• Patients with or without treatment for TOP, or with treatment not sufficiently effective

• Affiliated with the French social security scheme, universal medical coverages (CMU), or an equivalent scheme

• Signed informed consent

Exclusion Criteria:

• Psychiatric or neurological conditions (with the exception of POT)

• Presence of potential tsDCS risk factors including an electrically, magnetically or mechanically activated implant (including cardiac pacemaker, epidural stimulation electrodes, etc.), an intravascular clip or any other electrically sensitive support system, damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)

• Presence of TMS risk factor including cardiac pacemaker, history of epilepsy, traumatic brain injury with loss of consciousness, intracerebral clips, cochlear or ocular implants

• Pregnancy in women (as determined by a urine pregnancy test in pre-menopausal women), or lactating women or women planning pregnancy during the course of the study

• Patients enrolled in another biomedical research at the time of the study

• Participant who does not wish to be informed of any clinically relevant abnormalities (as determined by the investigators) identified during the course of the study

• Patient under guardianship or curatorship, or under judicial supervision

Related Conditions & MeSH terms

• Primary Orthostatic Tremor
• Tremor

Intervention

Device:
• tsDCS
20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder

Locations

Country	Name	City	State
France	Centre investigation clinique	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal time in the upright position without support	Force plateform	Before (PRE) and immediately after current offset (POST0)
Secondary	Quantitative assessment of tremor (EMG)		Before (PRE), immediately after (POST0) and 30min (POST30) current offset
Secondary	Cortical excitability assessed by Transcranial Magnetic Stimulation		Before (PRE), immediately after (POST0) and 30min (POST30) current offset