Clinical Trial: Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Trans-spinal Direct Current Stimulation in Primary Orthostatic Tremor

Brief 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.

Detailed Summary:

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
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Current Primary Outcome: Change in maximal time in the upright position without support [ Time Frame: Before (PRE) and immediately after current offset (POST0) ]

Force plateform


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quantitative assessment of tremor (EMG) [ Time Frame: Before (PRE), immediately after (POST0) and 30min (POST30) current offset ]
  • Cortical excitability assessed by Transcranial Magnetic Stimulation [ Time Frame: Before (PRE), immediately after (POST0) and 30min (POST30) current offset ]


Original Secondary Outcome: Same as current

Information By: Institut National de la Santé Et de la Recherche Médicale, France

Dates:
Date Received: November 22, 2016
Date Started: December 2016
Date Completion: March 2018
Last Updated: November 28, 2016
Last Verified: November 2016