Early Neurophysiological Interventions in Acute Cerebral Lesions

Summary

Objective:

Transcranial direct current stimulation (tDCS) can change the excitability of the central nervous system and contribute to motor recovery of stroke patients. The investigators hypothesized that the benefit of tDCS may increase with interventions facilitating motor responses, such as repetitive peripheral nerve stimulation (rPNS).

The aim of our study was to examine the short and long-term effects of real vs sham bihemispheric tDCS on scales of motor function and neurophysiological tests in patients with acute stroke and a moderate/severe motor impairment.

Methods:

The study was prospective, randomized, double-blind and placebo controlled. Twenty acute stroke patients (ischemic and haemorrhagic) with Upper limb Fugl-Meyer (ULFM) score\<19 were randomized in two parallel groups: one group received 5 consecutive daily sessions of anodal tDCS over the affected hemisphere (AH) and cathodal over unaffected hemisphere combined with rPNS and the other received sham tDCS associated to rPNS. Pacients were examined before tDCS, 5 days and 3, 6 and 12 months after tDCS. The investigators evaluated ULFM and modified Ashworth scales (MAS), resting motor threshold, motor and somatosensory evoked potentials (MEPs and SEPs), silent periods and Hmax/Mmax ratio.

Conditions

• Stroke
• Acute Stroke

Interventions

DEVICE

bihemispheric transcranial direct stimulation

tDCS was applied with the anode placed over the M1 hand area of the ipsilesional motor cortex and the cathode over the same area of the contralesional motor cortex (C3/C4). For the active condition, patients received 5 consecutive daily sessions of 2 mA anodal tDCS over the AH and cathodal tDCS over the UH of 20 minutes each, with fade-in and fade-out periods of 1s. For the sham condition, the stimulation applied in the same sites and with the same parameters, was turned off after a fade-in period, 30 seconds of direct current stimulation and a fade-out period. Repetitive peripheral nerve stimulation was performed by a peripheral nerve stimulator to the radial nerve and applied at the same time as tDCS. Radial nerve was chosen to improve wrist extension. Trains of 40 stimuli (ISI: 10 ms, duration: 1ms) were delivered every 6 seconds to the radial nerve through bipolar electrodes (5 cm diameter) at an intensity that could elicit a visible wrist extension (20-30 mA).

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  collaborator OTHER

• Sara Yagüe MD

  lead OTHER

Principal Investigators

• Jordi Montero, PhD · Hospital Universitari de Bellvitge

• Josep Valls-Solé, PhD · Clinic Hospital of Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-08

Primary Completion

2011-12-31

Completion

2013-11-09

Countries

• Spain

Study Locations