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Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

transcranial direct current stimulation

Sham stimulation

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
spinal onset
aged 18 to 85 years inclusive
disease duration ≤ 24 months
disease progression in the past 3 months
FVC ≥ 70% of predicted
score ≥ 2 at the item "swallowing"of the ALS Functional Rating Scale Revised
score ≥ 2 at the item "walking"of the ALS Functional Rating Scale Revised
in treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
able to give informed consent
written informed consent

Exclusion Criteria:

bulbar onset
previous poliomyelitis
motor neuron diseases other than ALS
clinical involvement of other neurological systems
pregnancy, lactation,or unwillingness to contraception if required
possible contraindications to tDCS: metals in the head (excluding the mouth); electromedical devices; seizures; drugs or neurological conditions lowering seizure threshold; alcoholism; severe heart diseases
any severe disease other than ALS
experimental drugs within 1 month prior to enrollment
drugs potentially modifying the response to tDCS

Sites / Locations

Centro Regionale Malattie Neuromuscolari, Ospedale Clinicizzato "SS. Annunziata"Recruiting
Azienda Policlinico Università Federico II
Policlinico Universitario Agostino Gemelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

tDCS

sham

Arm Description

Outcomes

Primary Outcome Measures

Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months

Secondary Outcome Measures

Decline of muscle strength from baseline to 12 months

A megascore will be obtained by summing scores of single muscles manually tested according to the Medical Research Council Scale

Change of upper motor neuron signs from baseline to 12 months

A score will be obtained based on presence/absence of listed upper motor neuron signs and grade of spasticity

Decline of forced vital capacity (percent of predicted normal) from baseline to 12 months

Change of quality of life from baseline to 12 months

The ALSAQ-40 questionnaire will be employed

Full Information

NCT ID

NCT01569958

First Posted

March 9, 2012

Last Updated

October 8, 2012

Sponsor

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Collaborators

Catholic University, Italy, Federico II University, Ministero della Salute, Italy

1. Study Identification

Unique Protocol Identification Number

NCT01569958

Brief Title

Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis

Official Title

Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

April 2016 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Collaborators

Catholic University, Italy, Federico II University, Ministero della Salute, Italy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease characterized by progressive weakness and muscular atrophy due to the degeneration and loss of motor neurons, the nerve cells that, in the central nervous system (motor cortex, brainstem and spinal chord), control voluntary movement. Riluzole, the only drug approved for ALS treatment, modestly slow disease progression. Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuromodulation that is currently studied as a possible therapeutic tool for several neurological and psychiatric diseases and has been found safe and well tolerated. Based on experimental evidence in animals and human subjects, tDCS is expected to reduce motor cortex excitability and excitotoxicity, that is neuronal injury induced by excessive glutamatergic stimulation, one of postulated pathophysiological mechanisms in ALS. This study will investigate if transcranial direct current stimulation of motor cortex is useful in delaying disease progression and is well tolerated in ALS patients.

Detailed Description

This is a double blind, randomized, placebo-controlled clinical trial. Cathodic tDCS (1 mA for 20 minutes) will be sequentially applied over the motor cortex of both sides, for five consecutive days every month for twelve months. The control group will receive a sham stimulation that reproduce tactile sensation of real stimulation but has no effects on central nervous system. For stimulation, researchers will employ a CE-certified medical device acting as a micro-processor-controlled constant current source. All patients will take riluzole during the entire period of the study. Fifty-four participants will be recruited from three Italian Centers and randomized to one of two arms of the study. Disease progression and quality of life will be evaluated at baseline and every three months during the study. At each visit adverse events will be reported and tolerability will be assessed through a specific questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tDCS

Arm Type

Active Comparator

Arm Title

sham

Arm Type

Sham Comparator

Intervention Type

Other

Intervention Name(s)

transcranial direct current stimulation

Intervention Description

transcranial direct current stimulation applied to the motor cortex of both sides (1 mA, 20 minutes) for five consecutive days every month for 12 months

Intervention Type

Other

Intervention Name(s)

Sham stimulation

Intervention Description

1 mA stimulation for 30 seconds every 900 seconds per session

Primary Outcome Measure Information:

Title

Decline of ALSFRS-R (ALS functional rating scale-revised) from baseline to 12 months

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Decline of muscle strength from baseline to 12 months

Description

A megascore will be obtained by summing scores of single muscles manually tested according to the Medical Research Council Scale

Time Frame

12 months

Title

Change of upper motor neuron signs from baseline to 12 months

Description

A score will be obtained based on presence/absence of listed upper motor neuron signs and grade of spasticity

Time Frame

12 months

Title

Decline of forced vital capacity (percent of predicted normal) from baseline to 12 months

Time Frame

12 months

Title

Change of quality of life from baseline to 12 months

Description

The ALSAQ-40 questionnaire will be employed

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria spinal onset aged 18 to 85 years inclusive disease duration ≤ 24 months disease progression in the past 3 months FVC ≥ 70% of predicted score ≥ 2 at the item "swallowing"of the ALS Functional Rating Scale Revised score ≥ 2 at the item "walking"of the ALS Functional Rating Scale Revised in treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation able to give informed consent written informed consent Exclusion Criteria: bulbar onset previous poliomyelitis motor neuron diseases other than ALS clinical involvement of other neurological systems pregnancy, lactation,or unwillingness to contraception if required possible contraindications to tDCS: metals in the head (excluding the mouth); electromedical devices; seizures; drugs or neurological conditions lowering seizure threshold; alcoholism; severe heart diseases any severe disease other than ALS experimental drugs within 1 month prior to enrollment drugs potentially modifying the response to tDCS

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessandra Lugaresi, MD, PhD

Organizational Affiliation

Università "G. d'Annunzio" di Chieti e Pescara, Dipartimento Neuroscienze ed Imaging, and ASL n. 2 Lanciano-Vasto-Chieti

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro Regionale Malattie Neuromuscolari, Ospedale Clinicizzato "SS. Annunziata"

City

Chieti

ZIP/Postal Code

66013

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Margherita Capasso, MD, PhD

Phone

00390871358585

neurolab@unich.it

First Name & Middle Initial & Last Name & Degree

Alessandra Lugaresi, MD, PhD

First Name & Middle Initial & Last Name & Degree

Margherita Capasso, MD,PhD

Facility Name

Azienda Policlinico Università Federico II

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lucio Santoro, MD

Facility Name

Policlinico Universitario Agostino Gemelli

City

Rome

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincenzo Di Lazzaro, MD

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation as a Novel Therapeutic Approach in Amyotrophic Lateral Sclerosis

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