Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness

Zhejiang University

Status: Unknown

Conditions: Disorder of Consciousness

Treatments: Other: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03385278

TMS

Details and patient eligibility

About

Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of rTMS with cross-over design.

Full description

Background:Repetitive transcranial magnetic stimulation (rTMS) was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented.

Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of high-frequency rTMS in DOC.

Method:In this randomised,sham-controlled study,real or sham 20 Hz rTMS were applied to the left primary motor cortex (M1) of participants with disorders of consciousness for 5 consecutive days . Evaluations were blindly performed at baseline, immediately after the end of the 5-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.

Hypothesis:Real rTMS can be an effective awakening method.

Enrollment: 10 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients ages 14 to 65 years old;
2. no centrally acting drugs;
3. no neuromuscular function blockers and no sedation within the prior 24 hours; 4.periods of eye opening (indicating preserved sleep-wake cycles);

5.DOC patients, including vegetative state and minimally consciousness state.

Exclusion criteria

1. History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
2. with a contraindication for rTMS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

10 participants in 2 patient groups

real-sham

Experimental group

Description:

the group first received real rTMS,then sham one.

Treatment:

Other: rTMS

sham-real

Experimental group

Description:

the group first received sham rTMS,then real one.

Treatment:

Other: rTMS