Transcranial Magnetic Stimulation in Patients with Dual Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

Repetitive Transcranial Magnetic Stimulation: The protocol will be applied with the MagVenture R30 stimulation device and the cool-B70 coil for active treatment. The protocol will consist of two sessions per day, with a 50-minute break between sessions, every day of the week (Monday to Friday) for three and a half weeks (a total of 36 sessions). Each session will consist of the application of a 1Hz protocol (2000 pulses at 120% of the motor threshold) in the right dorsolateral prefrontal cortex (F4) followed by an intermittent theta-burst protocol (1800 pulses at 90% of the motor threshold) in the left dorsolateral prefrontal cortex (F3). The cortical target localization will be performed using the beam-F3/F4 technique that combines different electroencephalographic positioning parameters and measurements to accurately locate said cortical targets. The motor threshold of each patient will be calculated at the beginning of each week of treatment using an electromyography system.

Transcranial Magnetic Stimulation Sham: The same protocol described in the intervention group will be carried out in the control group. The device used is the same, the difference is the coil that maintains the same appearance and generates the same sound as the active treatment coil, but unlike the latter, it does not produce an effective magnetization to depolarize the cerebral cortex on which we act.

Study summary

According to the WHO, 280 million people are diagnosed with depression, the prevalence of which is almost twice as high in women as in men, with the incidence among young people increasing in recent years. Another public health problem in Spain is tobacco consumption, with one in four adults being tobacco users. The presence of an addiction and another mental illness in the same patient is called dual disorder, and it is very common for depression to be associated with smoking. This is due to a shared biopsychosocial vulnerability between the two disorders. Although there are currently pharmacological treatments that address both disorders, their efficacy is limited; in this sense, transcranial magnetic stimulation (TMS) offers a way to treat these dual disorders. TMS is a technique in which a magnetic field is applied to the cortex through a coil, generating an electric current that can induce changes in the different neurotransmitter systems, stimulating or inhibiting them. A randomised, double-blind, placebo-controlled clinical trial is proposed to evaluate the efficacy of TMS in the treatment of a sample of 36 patients with resistant major depression and nicotine dependence. Both depression and smoking will be assessed at baseline, at various times during treatment and at the end of the study using psychometric tests, neurophysiological and biochemical assessments. It is expected that the experimental group will show improvements in depression, nicotine dependence and certain cognitive functions. TMS treatment of dual disorders (resistant depression + smoking) could represent a health and social advance, especially for women.

Eligibility

Primary outcome measure(s)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of transcranial magnetic stimulation in the treatment of resistant major depression and smoking, in patients with dual diagnosis.. — Baseline and day 5, 10, 15 and 18. Baseline and day 108 (booster doses completed).
  The tolerability of the treatment will be measured by means of a qualitative questionnaire (YES/NO), to be filled out by the patient. The possible side effects that will be taken into account are: epileptic crisis, manic shift, syncope, transient headache, localized pain in the area of application, neck pain, paresthesia, toothache, transient changes in hearing and scalp burns.
• Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression in patients with dual disorder through the Hamilton Rating Scale. — Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed).
  The effectiveness of the treatment applied will be through the evaluation of the changes produced in the affective symptoms. These changes will be evaluated with the following clinical scales: \- Hamilton Rating Scale for Depression (HDRS). Classification of symptoms: 0 - absent; 1 - mild; 2 - moderate; 3 - severe; 4 - incapacitating. In general the higher the total score the more severe the depression. HAM-D score level of depression: 10 - 13 mild; 14-17 mild to moderate; \>17 moderate to severe.
• Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression in patients with dual disorder through Clinical Global Impression Scale. — Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed)
  The effectiveness of the treatment applied will be through the evaluation of the changes produced in the affective symptoms. These changes will be evaluated with the following clinical scales: -Clinical Global Impression (CGI) The scale consists of two sections: severity of the disease and improvement. Scores range from 1 to 7. Higher scores correspond to more severe symptoms and no improvement. A score of 0 corresponds to no evaluation.
• Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression and smoking in patients with dual disorder. — Baseline. Baseline and day 9 and 18. Baseline and 3 months (booster doses completed)
  The effectiveness of the treatment applied will be through the evaluation of the changes produced in the affective symptoms. These changes will be evaluated with the following clinical scales: \- Montgomery-Asberg Depression Rating Scale (MADRS) It is a 10-item scale. For each item, the scale includes 7 levels of intensity/severity, scored from 0 to 6, of which 4 (0-2-4-6) are predefined and the remaining 3 (1-3-5) are reserved for intermediate situations in which it is not possible to clearly assign the degree of symptomatic intensity to any of the previous levels. A score below 10 points is considered to indicate the absence of depressive disorder.
• Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of smoking in patients with dual disorder. — Baseline. Baseline and day 9 and 18. Baseline and day 108 (booster doses completed)
  The effectiveness of the treatment applied will be through the evaluation of the changes produced in the tobacco addiction. These changes will be evaluated with the following clinical scales: \- Fagerström test for Nicotine Dependence The scale consists of 8 items, in which scores range from 0 to 10 points. Low dependency: 0-3 Moderate dependency: 4-7 High dependency: 8-10
• Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression and smoking in patients with dual disorder. — Baseline. Baseline and day 108 (booster doses completed)
  The effectiveness of the treatment applied will be through the evaluation of the changes produced in the tobacco addiction. These changes will be evaluated with the following clinical scales: \- Pack-year ratio calculation
• Evaluation of the efficacy of transcranial magnetic stimulation in the treatment of resistant major depression and smoking in patients with dual disorder. — Baseline. Day 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17 and 18. Baseline and day 108 (booster doses complete)
  The effectiveness of the treatment applied will be through the evaluation of the changes produced in the tobacco addiction. These changes will be evaluated with the following clinical scales: \- Smoking Diary

Trial sites (1)

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