Neuromodulation on Motor Function in Parkinson's Disease

NCT02250690 | Unknown DMC

• 1 other identifier: Parkinson_tDCS_Gait_Impairment
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aims of the present study was to analyze the effect of consecutive sessions of Transcranial direct current stimulation associated to kinesiotherapy about gait performance of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min) and stride length (m). The secondary outcome is motor cortex excitability which is analyzed by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor evoked potential amplitude (MEP) and rest motor threshold (rMT).

Conditions

Idiopathic Parkinsons Disease

Keywords

idiopathic PD; Hoehn and Yahr stage I to III; stable medication usage; age 40 to 80 years; absence of cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Change on Bradykinesia

  This outcome will be measure in three different moments of evaluation and at all interventions (sessions) days - before and after intervention. Beyond these evaluations, the voluntairs will be evaluate at: T1- before ten sessions; T2- Immediately after ten sessions and T3- after a period of 1 month without intervention.

  This outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten session

Secondary Outcomes (1)

• Change on Cortical excitability

  The evaluation occur in 3 different moments: before and after each session, after a period of 1 month without intervention. This outcome will be measure at all intervention and evaluation days

Other Outcomes (1)

• Change on Balance

  This outcome will be measure before ten sessions, 1 and 2 months after ten session

Study Arms (2)

experimental group - tDCS

EXPERIMENTAL

The tDCS intervention occur at 10 sessions of intervention where electrodes are connected to head specifically in supplementary motor area placed at 2 cm in front of vertex. The clinical stimulator (NeuroConn, Germany) provided the direct current using two silicon-sponge electrodes with a surface area of 35 cm2 (5 × 7cm) embedded in a saline-soaked solution. Immediately after 13 minutes of tDCS application, patient was submitted to gait training three times a week during 4 weeks with visuals cues. The patients were asked to walk along at a 7 meters rubber carpet to at different speed, forward and backward gait, side walk during thirty minutes with three intervals of two minutes. The patient may be at on state of drug administration and the training is applied by another physiotherapist.

Device: experimental group - tDCS

Control group (tDCS sham)

SHAM COMPARATOR

The sham character is ensured by the stimulation time, once the device is programmed to turn off 30 seconds after the beginning of stimulation. The current is switched in ascending ramp mode for 10 seconds until 2 mili ampere and a descending ramp similar also for 10 seconds will be used until the end of stimulation. The sham stimulation is commonly perceived by the patient as the actual treatment and all procedures for the application of the technique should be similar to those adopted for the active stimulation. Immediately after tDCS stimulation, the gait training consisting of a protocol based on sensory cues for 30 minutes is administered three times a week for four weeks. Sham stimulation will be held for 30 seconds in order to mimic the perceived lowering effect of ramp current.

Device: Control group (tDCS sham)

Interventions

experimental group - tDCS DEVICE

experimental group - tDCS

Control group (tDCS sham) DEVICE

Control group (tDCS sham)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main eligibility criteria were idiopathic Parkinson's disease
• Both sex
• Hoehn and Yahr stage I to III
• Showing mild to severe gait disturbances
• Stable medication usage
• Age 40 to 80 years
• And absence of cognitive impairment and disorders interfering with participation in cueing therapy.

You may not qualify if:

• Presence of chronic disabling pathologies of lower limb
• Presence of pacemaker or severe cardiovascular conditions
• A history of tumor, prior neurosurgical brain
• Intervention, or severe cardiovascular conditions, including the presence of a pacemaker
• A diagnosis of epilepsy or major psychiatric disorders.
• Participants with other neurological, muscular, or psychiatric disorders (e.g. peripheral neuropathies, uncorrected visual problems, hearing problems, vestibular dysfunction, stroke, seizure, migraine, or frequent severe headaches) were excluded.
• Participants with surgical implants, significant postural tremor, dyskinesia, severe freezing or dementia were also excluded.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transcranial direct current stimulation (tDCS) associated with gait training in improving motor function in Parkinson's disease.

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-07