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

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis (ALS)

• Registration Number: NCT06681610
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-24
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-08
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-04
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8.	baseline to week 8
Change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score	baseline to week 24	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.

Secondary Outcome Measures

Name	Time	Method
Changes in muscle strength, assessed by the Medical Research Council (MRC) sum score	baseline to week 4 and 8
Changes in hand-held dynamometry	baseline to week 8
Differences (treated vs sham) and change in the slow vital capacity (SVC)	from baseline to month 6
Change plasma neurofilament light chain (NfL) levels	baseline to week 4 and 8
Differences (treated vs sham) and change in plasma NfL levels	baseline to month 6	Candidate biomarkers are: SOD1, Ataxin 2, C90rf72, UNC13A, TDP43, stathmin 2, NfL and NfH levels
Change in Motor Evoked Potential (MEP) Amplitudes	baseline to week 4 and 8	ppTMS will be used to assess changes in motor cortex excitability via MEP amplitude (measured in millivolts)
Change in Resting Motor Threshold	baseline to week 4 and 8	RMT will be recorded to assess baseline motor cortex excitability (measured as a percentage of maximum stimulator output)
Change in Intra-Cortical Facilitation	baseline to week 4 and 8	ICF will be measured to assess synaptic excitability

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Catalonia, Spain