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Rehabilitative Trial for the Rescue of Neurophysiological Parameters in Progranulin Deficient Subjects (ReRescuePGR)

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ClinicalTrials.gov Identifier: NCT02999282
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia

Brief Summary:
In this randomized, double-blind, sham-controlled study, the investigators will evaluate the effects of frontal and prefrontal anodal transcranial direct current stimulation (tDCS) on neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic stimulation (TMS), in asymptomatic subjects at risk and symptomatic patients bearing a pathogenic Progranulin mutation.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia GRN Related Frontotemporal Dementia Device: Anodal transcranial direct current stimulation Device: Sham transcranial direct current stimulation Not Applicable

Detailed Description:

In this randomized, double-blind, sham-controlled study, the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation (tDCS) on neurophysiological parameters of cortical connectivity, assessed by transcranial magnetic stimulation (TMS), in asymptomatic subjects at risk and symptomatic patients bearing a pathogenic Progranulin mutation.

All patients will undergo genetic screening for progranulin mutations, a baseline neuropsychological and neurophysiological evaluation, including assessment of short interval intracortical inhibition, intracortical facilitation, short interval intracortical facilitation and long interval intracortical inhibition. Subjects will then be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal frontal and prefrontal anodal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a neuropsychological and neurophysiological evaluation at 2 weeks, 3 months and 6 month after treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Rehabilitative Trial for the Recovery of Neurophysiological Parameters in Progranulin Mutation Carriers Through the Use of Transcranial Direct Current Stimulation (tDCS)
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Experimental: Pretreated
Asymptomatic subjects - 10 days anodal transcranial direct current stimulation
Device: Anodal transcranial direct current stimulation
10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)

Sham Comparator: Preuntreated
Asymptomatic subjects - 10 days sham transcranial direct current stimulation
Device: Sham transcranial direct current stimulation
10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks)

Experimental: FTDtreated
Symptomatic patients - 10 days anodal transcranial direct current stimulation
Device: Anodal transcranial direct current stimulation
10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)

Sham Comparator: FTDuntreated
Symptomatic patients - 10 days sham transcranial direct current stimulation
Device: Sham transcranial direct current stimulation
10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks)




Primary Outcome Measures :
  1. Change in SICI measurements from Baseline [ Time Frame: Baseline - 2 weeks ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)

  2. Change in ICF measurements from Baseline [ Time Frame: Baseline - 2 weeks ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).

  3. Change in SICF measurements from Baseline [ Time Frame: Baseline - 2 weeks ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical facilitation (SICF).

  4. Change in LICI measurements from Baseline [ Time Frame: Baseline - 2 weeks ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on long interval intracortical inhibition (LICI)


Secondary Outcome Measures :
  1. Change in SICI measurements from Baseline [ Time Frame: Baseline - 1 month - 3 months ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical inhibition (SICI)

  2. Change in ICF measurements from Baseline [ Time Frame: Baseline - 1 month - 3 months ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on intracortical facilitation (ICF).

  3. Change in SICF measurements from Baseline [ Time Frame: Baseline - 1 month - 3 months ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on short interval intracortical facilitation (SICF).

  4. Change in LICI measurements from Baseline [ Time Frame: Baseline - 1 month - 3 months ]
    By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of frontal and prefrontal anodal transcranial magnetic stimulation on long interval intracortical inhibition (LICI).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients bearing a pathogenic mutation in the Progranulin gene

Exclusion Criteria:

  • Severe head trauma in the past
  • History of seizures
  • History of ischemic stroke or hemorrhage
  • Pacemaker
  • Metal implants in the head/neck region
  • Severe comorbidity
  • Intake of illegal drugs
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999282


Contacts
Contact: Barbara Borroni, MD +39 030 3995631 barbara.borroni@unibs.it

Locations
Italy
Azienda Ospedaliera Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
Principal Investigator: Barbara Borroni, MD Azienda Ospedaliera Spedali Civili, Brescia

Publications:
Responsible Party: Barbara Borroni, Associated Professor; MD, Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT02999282     History of Changes
Other Study ID Numbers: 2441
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Barbara Borroni, Azienda Ospedaliera Spedali Civili di Brescia:
TMS
tDCS
Rehabilitation

Additional relevant MeSH terms:
Frontotemporal Dementia
Pick Disease of the Brain
Dementia
Aphasia, Primary Progressive
Frontotemporal Lobar Degeneration
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms