Neuroplasticity:Melatonin and Transcranial Current Stimulation in Healthy Subjects.

Pain Clinical Trial

Official title:

Effect of Melatonin and Transcranial Direct Current Stimulation (tDCS) on Neuroplasticity and the Heat-pain Detection Threshold in Healthy Subjects:Randomized, Double-blind,Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02195271
• Other study ID #: 130155
• Status: Recruiting
• Phase: Phase 2
• First received: March 19, 2014
• Last updated: July 18, 2014
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: July 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Wolnei Caumo, PhD
• Phone: 555133598083
• Email: caumo[@]cpovo.net
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial Summary

Pain exerts a tremendous cost in healthy care, rehabilitation and lost productivity. It is is associated with a wide range of diseases and their social consequences is a public health problem.

With the progress of neuroscience and studies on the plasticity of the central nervous system, it has been provided a better understanding of the neurobiological mechanisms of pain.

The neurohormone Melatonin stands by having systemic and diverse mechanisms of action, both in physiological and pathological situations, with modulating effects on the process of nociceptive signaling and neurochemical mechanisms such as serotonergic, opioidergic and GABAergic, exerting anti-inflammatory action, analgesic activity among others.

The advent of neuromodulation techniques such as transcranial direct current stimulation (tDCS), which promote changes in neuronal activity and signaling to be effective in conditions of chronic pain by attenuating changes in cortical excitability.

There is clinical evidence of the analgesic effect of Melatonin and tDCS alone. Thus, considering the potential for each isolated intervention and the lack of knowledge of their combined effect, the authors propose the present study to investigate the effect of this combination on the heat-pain detection threshold and the neuroplasticity in the healthy subjects.

Description:

The methods are according to the CONSORT guidelines.

Heat pain threshold and tolerance : Quantitative Sensory Testing (QST) will be used on a computer Peltier-based device thermode.

Conditioned Pain Modulation (CPM)-task: Immerssing the non-dominant hand cold water for 1 minute.

Serum Brain Derived Neurotrophic Factor (BDNF).

Transcranial Magnetic Stimulation (TMS) assessment: motor threshold, motor evoked potential, Short intracortical inhibition and intracortical facilitation.

Statistical analyses: Descriptive statistics, Linear and multiple regression analysis, performed with SPSS version18.0.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male 18-40 years old

• Healthy

• Without medication

• Sign the informed consent

Exclusion Criteria:

• Patients who did not understand the Portuguese

• Acute or chronic pain conditions

• Medical or psychiatric disorders

• History of alcohol or substance abuse

• Neurological disorder

• Use of medications affect in the central nervous system

• Traumatic brain injury

• Neurosurgery

• Metallic implant in the brain

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Analgesia Disorder
• Pain

Intervention

Device:
• Transcranial Direct Current Stimulation (tDCS)

Drug:
• Melatonin

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in heat-pain threshold with pain score	Heat-threshold by Pettier-based device on the contralateral hand assessment pain score (VAS)	Baseline, one week	No
Secondary	Change from baseline Brain-Derived neurotrophic factor (BDNF)		Baseline, one week	No
Secondary	Change from Baseline from Catastrophizing Scale		Baseline, one week	No
Secondary	Change from baseline Inventory of state-trait anxiety Scale		Baseline, one week	No
Secondary	Change from baseline Inventory of Coping		Baseline, one week	No
Secondary	Change from baseline of cortical excitability	Transcranial Magnetic Stimulation (TMS) assessment motor threshold, motor-evoked potentials, silent period, intracortical inhibition and facilitation	Baseline, one week	No