The project will investigate the effectiveness of patient-centered integrated treatment. The correlations between physiotherapy indices, non-invasive brain stimulation, connectivity and psychological support will be analyzed.
At the time of recruitment (T0) a multidimensional evaluation will be performed consisting of clinical, neuropsychological, neurophysiological, MRI, data obtained from peripheral blood sampling (10ml). After completing the program (12 weeks), the effect will be assessed according to objectives (T1). The study will also include a follow-up evaluation after 6 months (T2) and 12 months (T3) from the beginning of the treatment to evaluate the persistence of the beneficial effects after some time.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The patient will be treated according to Lacanian psychoanalytic ethics, which allows to adequately respond to the patient's request for healing but who at the same time does not ignore the progress of scientific research in the neurological field
Physiotherapy treatment will be articulated through the use of techniques designed to qualify the functionality of the subject divided by symptom: weakness, dystonic attitudes of the limbs, walking disorders, tremor.
Diversified transcranial electrical maneuver protocols with an "on-line" or "off-line" approach may be applied for therapeutic purposes. This will include: transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), random noise stimulation (tRNS).
I.R.C.C.S. NEUROMED Istituto Neurologico Mediterraneo
Pozzilli, Isernia, Italy
RECRUITINGChanges and improvement in clinical condition
the Clinical global impression scale will be used. It is a brief 3-item observer-rated scale that assess severity of illness with assignable scores ranging from 0 to 7 (at every time time point), the global improvement with assignable scores ranging from 0 to 7 (from the second time point), and the efficacy index with assignable scores ranging from 1 to 16 (relationship between therapeutic efficacy and undesirable effects). Higher scores on these scales mean a worse outcome.
Time frame: 1-12 months
Changes in quality of life
The Short Form Health Survey 36 (SF-36) will be used. It is a generic, multidimensional tool, consisting of 36 questions that can be divided into 8 scales (Physical functioning, limitations due to physical health, limitations due to emotional problems, energy and fatigue, emotional well-being, social activities, pain, general health perception) expressed as percentage values 0-100%. Higher scores on these scales mean a better quality of life.
Time frame: 1-12 months
Changes in executive functions and attention - step 1
Will be used the Symbol Digit Modalities Test, which measures the processing speed, in the oral version of this test (Nocentini et al., 2006). The assignable performance's scores ranging from 0 to 110. The cut-off for normality in italian population for this oral version was 34.2. Higher scores on these scales mean a better processing speed.
Time frame: 1-12 months
Changes in executive functions and attention - step 2
Stroop test
Time frame: 1-12 months
Changes in neuroplasticity
Transcranial Magnetic Stimulation (TMS) will be used to evaluate the change of neuronal plasticity in a subgroup of patients who will not present contraindications to the method. The TMS uses short-lived magnetic fields and high intensity applied at the scalp level to activate the neurons of a small region of the cerebral cortex through an electromagnetic induction. When these impulses are applied repeatedly, it is possible to induce plastic modification of cortical excitability. Any increase or decrease in amplitude, which persists after the end of TMS repetitive stimulation, indicates that there have been changes in the cortical, long term potentiation (LTP) or depression (LTD).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1-12 months
Evaluation of genetic polymorphisms
A blood sample (10 ml) will be collected to investigate whether genetic polymorphisms related to patients' neuronal plasticity can be related to the response to the protocol.
Time frame: 1-12 months
Changes in behavioral aspects - step 1
State-Trait Anxiety Inventory-Form Y (STAI-Y). The STAI-Y is a self-report questionnaire consisting of two 20-item scales providing separate measures of state and trait anxiety, on a 4-point Likert scale, with scores ranges from 20 to 80, with higher scores indicating more severe outcome.
Time frame: 1-12 months
Changes in behavioral aspects - step 2
Beck Depression Inventory - Second Edition (BDI-II). BDI-II is a self-report questionnaire consisting of 21-item self-report scale designed to measure the severity of depressive symptoms, on a 4-point Likert scale, with scores ranges from 0 to 63, with higher scores indicating more severe outcome.
Time frame: 1-12 months
Changes in behavioral aspects - step 3
Toronto Alexithymia Scale (TAS-20). TAS-20 is a self-report questionnaire scale designed to measure alexithymia, on a 5-point Likert scale, with scores ranges from 20 to 100, with higher scores indicating more severe outcome.
Time frame: 1-12 months