Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study

Parc de Salut Mar50 enrolled

Overview

The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are: * Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8? * Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score? In stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score Participants will receive either: * the TPS treatment * a sham TPS treatment

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria * SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential * 21 to 80 years old and male or female Exclusion Criteria: * patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below

Outcomes

Primary Outcomes

Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.

Time frame: baseline to week 8

Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score

The ALS Functional Rating Scale-Revised Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Higher scores mean a better outcome.

Time frame: baseline to week 24

Secondary Outcomes

Change plasma neurofilament light chain (NfL) levels

Time frame: baseline to week 4 and 8

Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score

Time frame: baseline to week 4 and 8

Changes in hand-held dynamometry

Time frame: baseline to week 8

Differences (treated vs sham) and change in the slow vital capacity (SVC)

Time frame: from baseline to month 6

Differences (treated vs sham) and change in plasma NfL levels

Candidate biomarkers are: SOD1, Ataxin 2, C90rf72, UNC13A, TDP43, stathmin 2, NfL and NfH levels

Time frame: baseline to month 6

Change in Motor Evoked Potential (MEP) Amplitudes

ppTMS will be used to assess changes in motor cortex excitability via MEP amplitude (measured in millivolts)

Time frame: baseline to week 4 and 8

Change in Resting Motor Threshold

RMT will be recorded to assess baseline motor cortex excitability (measured as a percentage of maximum stimulator output)

Time frame: baseline to week 4 and 8

Change in Intra-Cortical Facilitation

ICF will be measured to assess synaptic excitability

Time frame: baseline to week 4 and 8

Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts