NCT02525393

Brief Summary

Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS. Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2015

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

August 11, 2015

Last Update Submit

August 13, 2015

Conditions

Stroke

Keywords

RehabilitationNon Invasive Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)

    Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment.

    Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months

Secondary Outcomes (2)

  • P300 (latency)

    Baseline; 1 month; 6 months and 1 week; 7 months

  • Cognition (standardized neuropsychological assessment)

    Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months

Study Arms (3)

tDCS+rTMS

EXPERIMENTAL

Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.

Device: tDCSDevice: rTMS

rTMS+tDCS

EXPERIMENTAL

Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.

Device: tDCSDevice: rTMS

Sham stimulation

SHAM COMPARATOR

Stroke patients were treated with two weeks of sham transcranial direct current stimulation.

Device: Sham

Interventions

tDCSDEVICE

Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.

Also known as: HDC Stim device Newronica
rTMS+tDCStDCS+rTMS
rTMSDEVICE

Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.

Also known as: PowerMAG 100 MAG&More
rTMS+tDCStDCS+rTMS
ShamDEVICE

Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.

Also known as: HDC Stim device Newronica
Sham stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ischemic or hemorrhagic stroke (\> 6 months from the accident)

You may not qualify if:

  • general cognitive impairment (Mini Mental State Examination \< 25), severe functional disability (Barthel Index \< 45),
  • psychiatric disorders,
  • degenerative neurological disorders,
  • epilepsy,
  • severe medical conditions,
  • having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Federico D'Agata, PhD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 17, 2015

Study Start

March 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

IT(1)