Status:

NOT_YET_RECRUITING

Transcranial Static Field Stimulation (tSMS) and Transcranial Direct Current Stimulation (tDCS) for the Treatment of Neurological Symptoms.

Lead Sponsor:

Neuromed IRCCS

Conditions:

Neurological Diseases or Conditions

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The presence of damage to the central and/or peripheral nervous system resulting from various pathologies, such as Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), Parkinson's disease (PD...

Eligibility Criteria

Inclusion

  • Males or females aged between 18 and 80 years;
  • Presence of a neurological disorder, specifically the following conditions will be considered: MS, ALS, PD, AD, Dementias, TBI, neurosurgical interventions, stroke, fibromyalgia, epilepsy, headache, migraine, with at least one of the following symptoms: pain, neuropathic pain, neuralgias, depression, anxiety, apathy, fatigue, cognitive decline, aphasia, functional motor disorders (FMD), neuromuscular tone alterations, hyposthenia, involvement of multiple cognitive functions (including decision-making, problem-solving, learning, memory, executive functions, social and emotional cognition);
  • Patients must be able to follow the protocol instructions for the duration of the study;
  • Be able to understand the purposes and risks of the study;
  • Be able to understand and provide written informed consent to the study.

Exclusion

  • Partial or total inability to understand or make decisions, inability to provide written informed consent for the study;
  • Patients with a history or presence of any unstable medical condition, such as neoplasms or infections;
  • Women with a positive pregnancy test at baseline or planning to become pregnant. Women who are breastfeeding or have given birth within the last three months prior to the start of the study;
  • Use of medications that increase the risk of seizures (e.g., Fampridine, 4-aminopyridine);
  • Concurrent use of medications that may alter synaptic transmission and plasticity (L-dopa, antiepileptics);
  • In the case of using NIBS techniques, subjects should not have any contraindications specific to this method (for further details, see the "Methods" and the "Stimulation Assessment Questionnaire" attached to this proposal).

Key Trial Info

Start Date :

May 11 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 11 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06900959

Start Date

May 11 2025

End Date

February 11 2026

Last Update

March 28 2025

Active Locations (1)

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1

Istituto Neurologico Mediterraneo IRCCS Neuromed

Pozzilli, Isernia, Italy, 86077